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
5501–5525 of 5945
Cleared Jan 21, 1981
ADC-500 AUTOMATED DIFFER. CELL CNTR. SY.
K803219 · Abbott Laboratories
GKZ · Counter, Differential Cell · 33d
Cleared Jan 12, 1981
INFLUENZA A & B S-ANTIGEN & CONTROLS
K802931 · Orion Diagnostica, Inc.
GNX · Antigens, Cf (including Cf Control), Influenza Virus A, B, C · 54d
Cleared Jan 12, 1981
MICROMEDIC REAGENT DISPENSER
K803252 · Micromedic Systems
JTC · Device, Microtiter Diluting/dispensing · 20d
Cleared Jan 12, 1981
MINI-TIP CULTURETTE
K803298 · Marion Laboratories, Inc.
JTW · System, Transport, Aerobic · 13d
Cleared Jan 09, 1981
CYTOMEGALO VIRUS & CONTROLS
K802930 · Orion Diagnostica, Inc.
GQH · Antigen, Cf (including Cf Control), Cytomegalovirus · 51d
Cleared Jan 08, 1981
BUFFERED CHARCOAL YEAST EXTRACT AGAR
K802757 · Remel Co.
JSJ · Culture Media, Selective And Non-differential · 65d
Cleared Dec 31, 1980
SELECTIVE CHARCOAL YEAST EXTRACT AGAR
K802758 · Remel Co.
JSJ · Culture Media, Selective And Non-differential · 57d
Cleared Dec 31, 1980
ADENO VIRUS & CONTROLS
K802929 · Orion Diagnostica, Inc.
GOD · Antigens, Cf (including Cf Control), Adenovirus 1-33 · 42d
Cleared Dec 31, 1980
MEASLES VIRUS & CONTROLS
K802932 · Orion Diagnostica, Inc.
GRJ · Antigen, Cf, (including Cf Control), Rubeola · 42d
Cleared Dec 31, 1980
MUMPS S & V ANTIGENS & CONTROLS
K802933 · Orion Diagnostica, Inc.
GRC · Antigen, Cf (including Cf Control), Mumps Virus · 42d
Cleared Dec 31, 1980
MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL
K802934 · Orion Diagnostica, Inc.
GSB · Antigens, Cf, All, Mycoplasma Spp. · 42d
Cleared Dec 31, 1980
PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR
K802935 · Orion Diagnostica, Inc.
GQS · Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4 · 42d
Cleared Dec 31, 1980
RESPIRATORY SYNCYTIAL VIRUS ANTIGEN &
K802936 · Orion Diagnostica, Inc.
GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 42d
Cleared Dec 31, 1980
RUBELLA VIRUS ANTIGENS & CONTROLS
K802937 · Orion Diagnostica, Inc.
GON · Antigen, Cf (including Cf Control), Rubella · 42d
Cleared Dec 31, 1980
VARICELLA-ZOSTER ANTIGENS & CONTROLS
K802938 · Orion Diagnostica, Inc.
GQW · Antigen, Cf, (including Cf Control), Varicella-zoster · 42d
Cleared Dec 31, 1980
HERPES SIMPLEX TYPE I
K802939 · Orion Diagnostica, Inc.
GON · Antigen, Cf (including Cf Control), Rubella · 42d
Cleared Dec 22, 1980
MYCOLOGY CULTURE SYSTEM
K802946 · Orion Diagnostica, Inc.
JSJ · Culture Media, Selective And Non-differential · 33d
Cleared Dec 22, 1980
ORICULT DTM
K802947 · Orion Diagnostica, Inc.
JSI · Culture Media, Selective And Differential · 33d
Cleared Dec 22, 1980
MUELLER HINTON BROTH
K802957 · Gibco Laboratories Life Technologies, Inc.
JTZ · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth · 35d
Cleared Dec 22, 1980
CDC ANAEROBE BLD AGAR W/KANAMYCIN ETC.
K803022 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSJ · Culture Media, Selective And Non-differential · 26d
Cleared Dec 22, 1980
ENRICHED THIOGLYCOLLATE MEDIUM
K803023 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSG · Culture Media, Non-selective And Non-differential · 26d
Cleared Dec 22, 1980
CDC ANAEROBE LAKED BL AGAR W/PARAMOMY.
K803024 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSJ · Culture Media, Selective And Non-differential · 26d
Cleared Dec 22, 1980
CDC ANAEROBE BLOOD AGAR
K803025 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSG · Culture Media, Non-selective And Non-differential · 26d
Cleared Dec 22, 1980
PEPTONE YEAST EXTRACT GLUCOSE BROTH
K803026 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSC · Culture Media, General Nutrient Broth · 26d
Cleared Dec 22, 1980
CDC ANAEROBE BL AGAR W/PHENYLETHYL ETC.
K803027 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSJ · Culture Media, Selective And Non-differential

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