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

7095
Total
7032
Cleared
150d
Avg (2y)
1976
Since
7095 Microbiology devices
2476–2500 of 7095
Cleared Sep 25, 1997
FRESH CELLS VERO
K973209 · Diagnostic Hybrids, Inc.
KIR · Cells, Animal And Human, Cultured · 29d
Cleared Sep 25, 1997
FRESH CELLS NCI H292
K973210 · Diagnostic Hybrids, Inc.
KIR · Cells, Animal And Human, Cultured · 29d
Cleared Sep 25, 1997
FRESH CELLS MV1LU
K973211 · Diagnostic Hybrids, Inc.
KIR · Cells, Animal And Human, Cultured · 29d
Cleared Sep 25, 1997
FRESH CELLS WI-38
K973212 · Diagnostic Hybrids, Inc.
KIR · Cells, Animal And Human, Cultured · 29d
Cleared Sep 25, 1997
FRESH CELLS LLC-MK2
K973213 · Diagnostic Hybrids, Inc.
KIR · Cells, Animal And Human, Cultured · 29d
Cleared Sep 25, 1997
FRESH CELLS HFF
K973214 · Diagnostic Hybrids, Inc.
KIR · Cells, Animal And Human, Cultured · 29d
Cleared Sep 17, 1997
RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE
K971508 · Bio-Whittaker, Inc., A Cambrex Co.
KIR · Cells, Animal And Human, Cultured · 145d
Cleared Sep 10, 1997
VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES
K971494 · Zymetx, Inc.
GNX · Antigens, Cf (including Cf Control), Influenza Virus A, B, C · 139d
Cleared Sep 08, 1997
STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS
K972030 · Oxoid , Ltd.
JWX · Kit, Screening, Staphylococcus Aureus · 98d
Cleared Sep 08, 1997
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K972524 · Dade Intl., Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 63d
Cleared Sep 08, 1997
MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN
K972688 · Dade Microscan, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 63d
Cleared Aug 29, 1997
FRESHCELLS
K972414 · Diagnostic Hybrids, Inc.
KIR · Cells, Animal And Human, Cultured · 63d
Cleared Aug 28, 1997
REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN
K972359 · Remel, L.P.
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 64d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA O GROUP B
K972386 · Lee Laboratories, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA O GROUP A
K972387 · Lee Laboratories, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA O GROUP C
K972388 · Lee Laboratories, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA H D
K972389 · Lee Laboratories, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA H C
K972390 · Lee Laboratories, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA H B
K972391 · Lee Laboratories, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA H A
K972392 · Lee Laboratories, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN BRUCELLA ABORTUS
K972394 · Lee Laboratories, Inc.
GSO · Antigens (febrile), Agglutination, Brucella Spp. · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA O GROUP D
K972395 · Lee Laboratories, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN BRUCELLA MELITENSIS
K972396 · Lee Laboratories, Inc.
GSO · Antigens (febrile), Agglutination, Brucella Spp. · 60d
Cleared Aug 22, 1997
ACCURUN 146 CMV IGM POSITIVE CONTROL
K972884 · Boston Biomedica, Inc.
LKQ · Antibody Igm,if, Cytomegalovirus Virus · 17d
Cleared Aug 20, 1997
MYCOPLASMA IGM ELISA TEST SYSTEM
K971503 · Zeus Scientific, Inc.
LJZ · Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. · 118d

Looking for a specific microbiology device? Search by device name, K-number or manufacturer.

Search all Microbiology 510(k) devices

Filter by Product Code

All categories 7095 JWY Manual Antimicrobial Susceptibility Test Systems 441 JTN Susceptibility Test Discs, Antimicrobial 323 JSJ Culture Media, Selective And Non-differential 299 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 291 JSI Culture Media, Selective And Differential 267 JTO Discs, Strips And Reagents, Microorganism Differentiation 239 JSG Culture Media, Non-selective And Non-differential 198 JSH Culture Media, Non-selective And Differential 142 LSR Reagent, Borrelia Serological Reagent 112 JSM Culture Media, Non-propagating Transport 110 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 104 GTZ Antisera, All Groups, Streptococcus Spp. 99 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 92 LYR Helicobacter Pylori 91 JSF Culture Media, Single Biochemical Test 87