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
5751–5775 of 5945
Cleared Sep 17, 1979
CYSTINE TRYPTIC AGAR
K791594 · Isle Media and Sterile Products, Inc.
JSH · Culture Media, Non-selective And Differential · 34d
Cleared Sep 17, 1979
BAIRD-PARKER AGAR
K791595 · Isle Media and Sterile Products, Inc.
JSJ · Culture Media, Selective And Non-differential · 34d
Cleared Sep 07, 1979
ANTIBODY TO HERPESVIRUS HOMINIS
K791058 · Electro-Nucleonics Laboratories, Inc.
GQO · Antisera, Cf, Herpesvirus Hominis 1,2 · 91d
Cleared Sep 04, 1979
SIMMONS CITRATE AGAR
K791474 · Isle Media and Sterile Products, Inc.
JSF · Culture Media, Single Biochemical Test · 39d
Cleared Sep 04, 1979
HEKTOEN ENTERIC AGAR
K791475 · Isle Media and Sterile Products, Inc.
JSI · Culture Media, Selective And Differential · 39d
Cleared Sep 04, 1979
.E.C MEDIUM (ESCHERICHIA COLI MEDIUM)
K791476 · Isle Media and Sterile Products, Inc.
JSF · Culture Media, Single Biochemical Test · 39d
Cleared Sep 04, 1979
XLD AGAR (XYLASE LYSINE DESOXY AGAR)
K791477 · Isle Media and Sterile Products, Inc.
JSI · Culture Media, Selective And Differential · 36d
Cleared Sep 04, 1979
FLUID THIOGLYCOLLATE MEDIUM
K791478 · Isle Media and Sterile Products, Inc.
JSC · Culture Media, General Nutrient Broth · 36d
Cleared Sep 04, 1979
ENDO AGAR
K791479 · Isle Media and Sterile Products, Inc.
JSI · Culture Media, Selective And Differential · 36d
Cleared Aug 28, 1979
BIOASSAY SYSTEM, MS-2 SERUM
K782049 · Abbott Laboratories
DJB · Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. · 263d
Cleared Aug 22, 1979
API 20E REAGENT QC
K791222 · Analytical Products, Inc.
JSE · Culture Media, Multiple Biochemical Test · 50d
Cleared Aug 22, 1979
CULTURE MEDIA FOR INSOLATION NEISSERIA
K791398 · Isle Media and Sterile Products, Inc.
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 29d
Cleared Aug 22, 1979
MODIFIED THAYER-MARTIN MEDIUM
K791470 · Isle Media and Sterile Products, Inc.
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 29d
Cleared Aug 22, 1979
SELENITE CYSTINE BROTH
K791471 · Isle Media and Sterile Products, Inc.
JSD · Culture Media, Selective Broth · 23d
Cleared Aug 22, 1979
PHENYLETHANOL AGAG (PEA)
K791472 · Isle Media and Sterile Products, Inc.
JSI · Culture Media, Selective And Differential · 23d
Cleared Aug 22, 1979
TRIPLE SUGAR IRON AGAR (TSI AGAR)
K791473 · Isle Media and Sterile Products, Inc.
JSE · Culture Media, Multiple Biochemical Test · 26d
Cleared Aug 22, 1979
SS AGAR (SALMONELLA SHIGELLA AGAR)
K791480 · Isle Media and Sterile Products, Inc.
JSI · Culture Media, Selective And Differential · 23d
Cleared Aug 22, 1979
LAURYL TRYPTOSE BROTH
K791481 · Isle Media and Sterile Products, Inc.
JSD · Culture Media, Selective Broth · 23d
Cleared Aug 22, 1979
MACCONKEY MEDIA
K791482 · Isle Media and Sterile Products, Inc.
JSI · Culture Media, Selective And Differential · 23d
Cleared Aug 22, 1979
THAYER-MARTIN MEDIUM
K791483 · Isle Media and Sterile Products, Inc.
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 29d
Cleared Aug 22, 1979
SELENITE BROTH
K791484 · Isle Media and Sterile Products, Inc.
JSD · Culture Media, Selective Broth · 23d
Cleared Aug 22, 1979
MUELLER HINTON AGARS
K791485 · Isle Media and Sterile Products, Inc.
JTZ · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth · 29d
Cleared Aug 22, 1979
TRANSPORT MEDIUM STUART
K791514 · Isle Media and Sterile Products, Inc.
JSM · Culture Media, Non-propagating Transport · 14d
Cleared Aug 22, 1979
TRANSPORT MEDIUM STUART W/ CHARCOAL
K791515 · Isle Media and Sterile Products, Inc.
JSM · Culture Media, Non-propagating Transport · 14d
Cleared Aug 22, 1979
TRYPTIC SOY AGAR
K791516 · Isle Media and Sterile Products, Inc.
JSG · Culture Media, Non-selective And Non-differential · 14d

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