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
150d
Avg (2y)
1976
Since
5941 Microbiology devices
4076–4100 of 5941
Cleared Feb 03, 1987
LEECO VIS-CUBE STREP A (EIA)
K864170 · Leeco Diagnostics, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 102d
Cleared Feb 03, 1987
GC-LECT(TM)
K864803 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 56d
Cleared Feb 02, 1987
MICRODILUTION MIC PANELS
K863776 · American Micro Scan
JWY · Manual Antimicrobial Susceptibility Test Systems · 130d
Cleared Feb 02, 1987
CMV MICROASSAY
K864420 · Diamedix Corp.
GQI · Antiserum, Cf, Cytomegalovirus · 84d
Cleared Feb 02, 1987
REVISED RESISTANT 5 MIC PANEL
K864493 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 80d
Cleared Feb 02, 1987
PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM
K864663 · Kallestad Diag, A Div. of Erbamont, Inc.
LJP · Antiserum, Fluorescent, Chlamydia Trachomatis · 66d
Cleared Jan 21, 1987
WELLCOZYME ROTAVIRUS WZ01
K861628 · Wellcome Diagnostics
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 267d
Cleared Jan 13, 1987
REVEAL COLOUR STREP A ZL16
K864206 · Wellcome Diagnostics
GTZ · Antisera, All Groups, Streptococcus Spp. · 78d
Cleared Jan 05, 1987
MICRODILUTION IDENTIFICATION PANELS
K864674 · American Micro Scan
JSE · Culture Media, Multiple Biochemical Test · 34d
Cleared Jan 05, 1987
PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM
K864755 · Gibco Laboratories Life Technologies, Inc.
JSJ · Culture Media, Selective And Non-differential · 31d
Cleared Dec 22, 1986
BINAX STREP A
K863908 · Binax, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 76d
Cleared Dec 18, 1986
LKB ULTROBACT (TM) PNEUMOCOCCUS KIT
K862848 · Lkb Instruments, Inc.
GWC · Antisera, All Types, Streptococcus Pneumoniae · 142d
Cleared Dec 12, 1986
SYPH-TRUST
K863368 · I.A.F. Production, Inc.
GMQ · Antigens, Nontreponemal, All · 100d
Cleared Dec 11, 1986
BBL CAMPYSLIDE(TM) TEST
K864027 · Bd Becton Dickinson Vacutainer Systems Preanalytic
LQP · Campylobacter Spp. · 57d
Cleared Dec 04, 1986
CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST
K864389 · American Micro Scan
LJP · Antiserum, Fluorescent, Chlamydia Trachomatis · 28d
Cleared Dec 03, 1986
PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM
K863681 · Kallestad Laboratories, Inc.
LJP · Antiserum, Fluorescent, Chlamydia Trachomatis · 75d
Cleared Nov 28, 1986
EBV/VCA-CHECK(TM) ANTIGEN SLIDES
K863408 · Diagnostic Technology, Inc.
GNP · Antiserum, Cf, Epstein-barr Virus · 86d
Cleared Nov 28, 1986
TOXOPLASMA IGG MICROASSAY
K863813 · Diamedix Corp.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 59d
Cleared Nov 26, 1986
CARDS(TM) STREP A CATALOG NO. CR-7545
K863647 · Pacific Biotech, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 69d
Cleared Nov 24, 1986
THERMONUCLEASE AGAR W/TOLUIDINE BLUE
K864205 · Remel Co.
JSH · Culture Media, Non-selective And Differential · 28d
Cleared Nov 13, 1986
PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID
K864069 · Austin Biological Laboratories
JWY · Manual Antimicrobial Susceptibility Test Systems · 24d
Cleared Nov 10, 1986
RAPID IDENT. TEST FOR MYCOBACTERIUM AVIUM COMPLEX
K862613 · Gen-Probe, Inc.
LQF · Dna-reagents, Mycobacterium Spp. · 124d
Cleared Nov 10, 1986
RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX
K862614 · Gen-Probe, Inc.
LQF · Dna-reagents, Mycobacterium Spp. · 124d
Cleared Nov 05, 1986
OXOID SIGNAL BLOOD CULTURE SYSTEM
K862946 · Oxoid U.S.A., Inc.
JSG · Culture Media, Non-selective And Non-differential · 92d
Cleared Nov 05, 1986
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT
K863490 · Ortho Diagnostic Systems, Inc.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 57d

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 5941 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