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
5939 Microbiology devices
3801–3825 of 5939
Cleared Dec 09, 1987
MERITEC(TM)-GC
K874078 · Meridian Diagnostics, Inc.
LIC · Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae · 64d
Cleared Dec 09, 1987
API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC
K874466 · Analytical Products, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 37d
Cleared Dec 02, 1987
NEW ANTIMICRO. AGENTS:AUGMENTIN,AZTREONAM,CIPROFLO
K874426 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JWY · Manual Antimicrobial Susceptibility Test Systems · 35d
Cleared Nov 27, 1987
ROTASCREEN EIA
K873740 · Mercia Diagnostics , Ltd.
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 73d
Cleared Nov 20, 1987
BINAX EQUATE STREP B
K872904 · Binax, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 119d
Cleared Nov 20, 1987
AMPICILLIN/SULBACTAM 10/10 MCG SUSCEPTIBILITY DISK
K874256 · Organon Teknika Corp.
JTN · Susceptibility Test Discs, Antimicrobial · 31d
Cleared Nov 20, 1987
CIPROFLOXACIN 5 MCG SENSI-DISC
K874425 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 23d
Cleared Nov 20, 1987
KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR
K874537 · Lakewood Biochemical Co., Inc.
JSE · Culture Media, Multiple Biochemical Test · 17d
Cleared Nov 20, 1987
TODD-HEWITT BROTH (0.5ML)#3099 & (5.OML)#T3516
K874538 · Lakewood Biochemical Co., Inc.
JSG · Culture Media, Non-selective And Non-differential · 17d
Cleared Nov 20, 1987
DYNATECH MR 250 MANUAL MICROELISA READER
K874598 · Dynatech Laboratories, Inc.
JTC · Device, Microtiter Diluting/dispensing · 11d
Cleared Nov 06, 1987
STAPHYLASE TEST
K874303 · Oxoid U.S.A., Inc.
LHT · Staphylococcus Aureus Somatic Antigens · 17d
Cleared Nov 06, 1987
QUAD PLATE (4 DIFFERENT MEDIA)
K874344 · Lakewood Biochemical Co., Inc.
JSI · Culture Media, Selective And Differential · 17d
Cleared Nov 06, 1987
TSA W/NEOMYCIN & 5% SHEEP BLOOD - # P3104 & Z3050
K874345 · Lakewood Biochemical Co., Inc.
JSJ · Culture Media, Selective And Non-differential · 17d
Cleared Oct 28, 1987
RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS
K871878 · Gen-Probe, Inc.
LSK · Dna-reagents, Chlamydia · 167d
Cleared Oct 23, 1987
MICRO CULTURE MEDIA P3528, P3137, P3149, P3139
K873951 · Lakewood Biochemical Co., Inc.
JSJ · Culture Media, Selective And Non-differential · 25d
Cleared Oct 23, 1987
MICRO CULTURE MEDIA P3141, P3136, P3148, P3748
K873952 · Lakewood Biochemical Co., Inc.
KZI · Culture Media, Enriched · 25d
Cleared Oct 23, 1987
PHENYLETHYL ALCOHOL AGAR(PEA) W/5% SHEEP #P3323
K873975 · Lakewood Biochemical Co., Inc.
JSJ · Culture Media, Selective And Non-differential · 24d
Cleared Oct 15, 1987
VIROGEN HSV ANTIBODY TEST
K871426 · Armkel, LLC
GQO · Antisera, Cf, Herpesvirus Hominis 1,2 · 189d
Cleared Oct 15, 1987
FIAX TEST KIT FOR LYME DISEASE ANTIBODIES
K872247 · Whittaker Bioproducts, Inc.
LSR · Reagent, Borrelia Serological Reagent · 126d
Cleared Oct 15, 1987
MODIFICATION RUBELLA IGM EIA TEST KIT
K873780 · Labsystems, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 35d
Cleared Oct 08, 1987
COL. CNA 5% SB/MACCONKEY AGAR BIPLATE # Z3206
K873479 · Lakewood Biochemical Co., Inc.
JSJ · Culture Media, Selective And Non-differential · 42d
Cleared Oct 08, 1987
TSA 5% SHEEP BLOOD/EMB AGAR - PRODUCT #Z3023
K873480 · Lakewood Biochemical Co., Inc.
JSG · Culture Media, Non-selective And Non-differential · 42d
Cleared Oct 08, 1987
HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016
K873481 · Lakewood Biochemical Co., Inc.
JSI · Culture Media, Selective And Differential · 42d
Cleared Oct 08, 1987
TSA 5% SHEEP BLOOD (SB)/MACCONKEY AGAR #Z3033
K873482 · Lakewood Biochemical Co., Inc.
JSG · Culture Media, Non-selective And Non-differential · 42d
Cleared Oct 08, 1987
TSA 5% SHEEP BLOOD (SB)/LEVINE EMB AGAR #Z3020
K873483 · Lakewood Biochemical Co., Inc.
JSG · Culture Media, Non-selective And Non-differential · 42d

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All categories 5939 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 99 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