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
5945 Microbiology devices
5526–5550 of 5945
Cleared Dec 22, 1980
THE BIO-TEK CHROMOSCAN
K803030 · Bio-Tek Instruments, Inc.
JJQ · Colorimeter, Photometer, Spectrophotometer For Clinical Use · 24d
Cleared Dec 22, 1980
SAF FIXATIVE
K803054 · Remel Co.
IGB · Solution, Formalin-sodium Acetate · 20d
Cleared Dec 22, 1980
MIC-BIOPLATE INOCULATOR
K803092 · Pasco Laboratories, Inc.
JQW · Station, Pipetting And Diluting, For Clinical Use · 14d
Cleared Dec 18, 1980
EIA RUBELLA-G
K802339 · Beckman Instruments, Inc.
GOL · Antigen, Ha (including Ha Control), Rubella · 83d
Cleared Dec 18, 1980
TOXOTEST-MT EIKEN KIT
K802452 · Syn-Kit, Inc.
GMM · Antigens, Iha, Toxoplasma Gondii · 71d
Cleared Dec 18, 1980
CLOSTRIDIUM DIFFICILE AGAR BASE
K802495 · Oxoid U.S.A., Inc.
JSJ · Culture Media, Selective And Non-differential · 69d
Cleared Dec 16, 1980
CYE BIPHASIC BLOOD CULTURE MEDIUM
K802571 · Remel Co.
JSJ · Culture Media, Selective And Non-differential · 60d
Cleared Dec 11, 1980
IMMULON REMOVAWELL STRIPS #011-010-6301
K802857 · Dynatech Corp.
JTC · Device, Microtiter Diluting/dispensing · 29d
Cleared Dec 01, 1980
MS-2 IDENTIFICATION SYSTEM
K802309 · Abbott Laboratories
JXB · Kit, Identification, Yeast · 69d
Cleared Nov 12, 1980
PHADEBACT HAEMOPHILUS TEST
K802423 · Pharmacia, Inc.
GRO · Antisera, Fluorescent, All Types, Hemophilus Spp. · 40d
Cleared Nov 12, 1980
SPUTASOL
K802493 · Oxoid U.S.A., Inc.
IBG · Trypsin · 33d
Cleared Nov 12, 1980
GAS GENERATING KIT SYSTEM FOR CAMPYLOB.
K802494 · Oxoid U.S.A., Inc.
KZJ · Device, Gas Generating · 33d
Cleared Nov 12, 1980
OPTOCHIN DIAGNOSTIC DISC
K802496 · Oxoid U.S.A., Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 33d
Cleared Nov 12, 1980
BACTIRACIN DIAGNOSTIC DISC
K802497 · Oxoid U.S.A., Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 33d
Cleared Nov 12, 1980
MUELLER HINTON AGAR
K802498 · Oxoid U.S.A., Inc.
JTZ · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth · 33d
Cleared Nov 12, 1980
X-FACTOR DISCS
K802500 · Oxoid U.S.A., Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 33d
Cleared Nov 12, 1980
V FACTOR DISCS
K802501 · Oxoid U.S.A., Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 33d
Cleared Nov 12, 1980
X & V FACTOR DISCS
K802502 · Oxoid U.S.A., Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 33d
Cleared Nov 12, 1980
ANAIROBE-TEK
K802626 · Flow Laboratories, Inc.
JSP · Kit, Anaerobic Identification · 20d
Cleared Oct 31, 1980
VIRAL TRANSPORT MED. (46-995-04)
K802303 · Flow Laboratories, Inc.
JSM · Culture Media, Non-propagating Transport · 38d
Cleared Oct 31, 1980
PHADEBACT PNEUMOCOCCUS TEST
K802337 · Pharmacia, Inc.
GWC · Antisera, All Types, Streptococcus Pneumoniae · 35d
Cleared Oct 31, 1980
BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT
K802415 · Remel Co.
JSG · Culture Media, Non-selective And Non-differential · 25d
Cleared Oct 31, 1980
LA-SPORO ANTIBODY SYSTEM
K802427 · Immuno-Mycologics, Inc.
GMA · Antisera, Fluorescent, Sporothrix Schenekii · 25d
Cleared Oct 31, 1980
HI VOLUME PUMPING CHAMBER
K802561 · Acacia, Inc.
JTB · Device, Media Dispensing/stacking · 15d
Cleared Oct 31, 1980
BETA LACTAMASE REAGENT DISK
K802566 · Carr-Scarborough Microbiologicals, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 14d

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All categories 5945 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 LYR Helicobacter Pylori 75 OCC Respiratory Virus Panel Nucleic Acid Assay System 75