FDA Review Panel · MI

FDA 510(k) Microbiology Devices

FDA 510(k) Microbiology Devices - Regulatory Overview

FDA 510(k) microbiology devices include diagnostic systems used to detect and identify bacteria, viruses, fungi and parasites. The FDA review panel code is MI.

Key device types:

  • Blood culture systems - automated incubation and detection platforms
  • Microbial identification - MALDI-TOF, biochemical and molecular ID systems
  • Antimicrobial susceptibility testing - MIC determination and breakpoint analysis
  • Rapid infectious disease tests - influenza, strep, RSV, COVID-19 antigen and molecular tests
  • Molecular diagnostics - PCR panels for respiratory, GI and STI pathogens

7067
Total
7005
Cleared
149d
Avg (2y)
1976
Since
5932 Microbiology devices
2626–2650 of 5932
Cleared Mar 12, 1996
SAS SALMONELLA O GROUP Z FACTOR 50 ANTISERUM
K960130 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 61d
Cleared Mar 12, 1996
SAS SALMONELLA 0 GROUP E FACTORS 1,3,10,15,19,34 ANTISERUM
K960147 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 61d
Cleared Mar 12, 1996
SAS SALMONELLA 0 GROUP M FACTOR 28 ANTISERUM
K960160 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 61d
Cleared Mar 12, 1996
SAS SALMONELLA O GROUP R FACTOR 40 ANTISERUM
K960461 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 42d
Cleared Mar 11, 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K960220 · Sensititre , Ltd.
JWY · Manual Antimicrobial Susceptibility Test Systems · 55d
Cleared Mar 06, 1996
SAS SALMONELLA O FACTOR 18 ANTISERUM &/OR SAS SALMONELLA O GROUP K FACTOR 18 ANTISERUM
K960123 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA 0 FACTOR 10 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP E1 FACTOR 10 ANTISERUM
K960124 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA O FACTOR 4 ANTISERUM &/OR SAS SALMONELLA O GROUP B FACTOR 4,5 ANTISERUM
K960125 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA O FACTOR 19 ANTISERUM &/OR SAS SALMONELLA O GROUP E4 FACTOR 19 ANTISERUM
K960126 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA O FACTOR 22 ANTISERUM &/OR SAS SALMONELLA O GROUP G1 FACTOR 22 ANTISERUM
K960127 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA H U ANTISERUM
K960132 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 50d
Cleared Mar 06, 1996
SAS SALMONELLA 0 FACTOR 9 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP D FACTOR 9 ANTISERUM
K960134 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA H M ANTISERUM
K960135 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 50d
Cleared Mar 06, 1996
SAS SALMONELLA H P ANTISERUM
K960136 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 50d
Cleared Mar 06, 1996
SAS SALMONELLA H Z10 ANTISERUM
K960137 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 50d
Cleared Mar 06, 1996
SAS SALMONELLA 0 FACTOR 8 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP C2 FACTOR 9 ANTISERUM
K960138 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA 0 FACTOR ANTISERUM AND/OR SAS SALMONELLA 0 GROUP C1 FACTOR 7 ANTISERUM
K960140 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA 0 FACTOR 23 ANTISERUM AND/OR SAS SLAMONELLA 0 GROUP G2 FACTOR 23 ANTISERUM
K960142 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA 0 FACTOR 27 ANTISERUM
K960145 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA 0 GROUP F FACTOR 11 ANTISERUM
K960149 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA 0 GROUP J FACTOR 17 ANTISERUM
K960150 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA 0 FACTOR 12 ANTISERUM
K960152 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALOMNELLA 0 GROUP L FACTOR 21 ANTISERUM
K960153 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA 0 GROUP N FACTOR 30 ANTISERUM
K960161 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA 0 GROUP 0 FACTOR 35 ANTISERUM
K960162 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d

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All categories 5932 JWY Manual Antimicrobial Susceptibility Test Systems 408 JTN Susceptibility Test Discs, Antimicrobial 316 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 284 JSJ Culture Media, Selective And Non-differential 264 JSI Culture Media, Selective And Differential 216 JTO Discs, Strips And Reagents, Microorganism Differentiation 194 JSG Culture Media, Non-selective And Non-differential 181 JSH Culture Media, Non-selective And Differential 115 LSR Reagent, Borrelia Serological Reagent 98 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 94 GTZ Antisera, All Groups, Streptococcus Spp. 84 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 79 JSM Culture Media, Non-propagating Transport 77 OCC Respiratory Virus Panel Nucleic Acid Assay System 75 LYR Helicobacter Pylori 75