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
4026–4050 of 5941
Cleared Mar 31, 1987
GARNERELLA VAGINALIS IDENTIFICATION KIT
K864244 · Mds Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 154d
Cleared Mar 31, 1987
MUELLER HINTON AGAR SMALL
K864245 · Mds Laboratories, Inc.
JTZ · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth · 154d
Cleared Mar 31, 1987
MUELLER HINTON AGAR LARGE
K864246 · Mds Laboratories, Inc.
JTZ · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth · 154d
Cleared Mar 31, 1987
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
K864247 · Mds Laboratories, Inc.
JTZ · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth · 154d
Cleared Mar 31, 1987
MUELLER HINTON AGAR - SUPPLEMENTED
K864248 · Mds Laboratories, Inc.
JTZ · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth · 154d
Cleared Mar 31, 1987
NORMAL SALINE STERILE
K864249 · Mds Laboratories, Inc.
LIB · Device, General Purpose, Microbiology, Diagnostic · 154d
Cleared Mar 31, 1987
SABOURAUD DEXTROSE AGAR
K864250 · Mds Laboratories, Inc.
JSJ · Culture Media, Selective And Non-differential · 154d
Cleared Mar 31, 1987
SELENITE F. BROTH
K864251 · Mds Laboratories, Inc.
JSJ · Culture Media, Selective And Non-differential · 154d
Cleared Mar 31, 1987
THAYER-MARTIN JEMBEC
K864252 · Mds Laboratories, Inc.
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 154d
Cleared Mar 31, 1987
THAYER MARTIN AGAR
K864253 · Mds Laboratories, Inc.
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 154d
Cleared Mar 31, 1987
THIOGLYCOLLATE BROTH
K864254 · Mds Laboratories, Inc.
JSG · Culture Media, Non-selective And Non-differential · 154d
Cleared Mar 31, 1987
TRYPTICASE SOY BROTH
K864255 · Mds Laboratories, Inc.
JSG · Culture Media, Non-selective And Non-differential · 154d
Cleared Mar 31, 1987
TRYPTONE WATER (1%)
K864256 · Mds Laboratories, Inc.
JSF · Culture Media, Single Biochemical Test · 154d
Cleared Mar 31, 1987
T7202 THIO W/O IND W/DEXTROSE
K870798 · Lakewood Biochemical Co., Inc.
JSG · Culture Media, Non-selective And Non-differential · 32d
Cleared Mar 31, 1987
T2500 FLUID THIO
K870799 · Lakewood Biochemical Co., Inc.
JSG · Culture Media, Non-selective And Non-differential · 32d
Cleared Mar 31, 1987
T2570 THIO W/O IND W/O DEXTROSE
K870800 · Lakewood Biochemical Co., Inc.
JSG · Culture Media, Non-selective And Non-differential · 32d
Cleared Mar 31, 1987
RF MICROASSAY
K871041 · Diamedix Corp.
DHR · System, Test, Rheumatoid Factor · 14d
Cleared Mar 30, 1987
T4013 TSB 5ML
K870592 · Lakewood Biochemical Co., Inc.
JSG · Culture Media, Non-selective And Non-differential · 48d
Cleared Mar 30, 1987
T9000 TSB 10ML
K870593 · Lakewood Biochemical Co., Inc.
JSG · Culture Media, Non-selective And Non-differential · 48d
Cleared Mar 30, 1987
T9802 TSB W/6.5% NACL
K870594 · Lakewood Biochemical Co., Inc.
JSD · Culture Media, Selective Broth · 48d
Cleared Mar 30, 1987
T4012 TSB 2ML
K870595 · Lakewood Biochemical Co., Inc.
JSG · Culture Media, Non-selective And Non-differential · 48d
Cleared Mar 25, 1987
CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS
K864662 · American Micro Scan
LJP · Antiserum, Fluorescent, Chlamydia Trachomatis · 117d
Cleared Mar 25, 1987
ALADIN (TM)
K865062 · Analytical Products, Inc.
LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 91d
Cleared Mar 25, 1987
IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE
K870029 · American Micro Scan
GWC · Antisera, All Types, Streptococcus Pneumoniae · 79d
Cleared Mar 23, 1987
API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT(R)MIC
K870663 · Analytical Products, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 32d

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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