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
5876–5900 of 5945
Cleared Jan 20, 1978
RUBENOSTICON
K780063 · Organon, Inc.
GOK · Antisera, Hai (including Hai Control), Rubella · 8d
Cleared Jan 05, 1978
FLUORESCEIN CONJUG. FRACT. MONO. ANTI.
K772345 · Kallestad Laboratories, Inc.
DCB · Fab, Fitc, Antigen, Antiserum, Control · 13d
Cleared Dec 20, 1977
CULTURE COLLEC. TRANS. SYS., SINGLE WET
K772207 · Precision Dynamics Corp.
JTW · System, Transport, Aerobic · 19d
Cleared Dec 20, 1977
CULTURE COLLEC. TRANS. SYS., DOUBLE DRY
K772209 · Precision Dynamics Corp.
JTW · System, Transport, Aerobic · 19d
Cleared Dec 14, 1977
HERPES I.D. TM TEST
K771445 · Hyland Therapeutic Div., Travenol Laboratories
GQL · Antisera, Fluorescent, Herpesvirus Hominis 1,2 · 135d
Cleared Dec 09, 1977
MICROCULT-ID
K771672 · Miles Laboratories, Inc.
JXA · Kit, Screening, Urine · 99d
Cleared Dec 09, 1977
CULTURE COLLEC. TRANS. SYS., DOUBLE WET
K772205 · Precision Dynamics Corp.
JTW · System, Transport, Aerobic · 8d
Cleared Dec 09, 1977
CULTURE COLLEC. TRANS. SYS., SINGLE WET
K772206 · Precision Dynamics Corp.
JTW · System, Transport, Aerobic · 8d
Cleared Dec 09, 1977
CULTURE COLLEC. TRANS. SYS., SINGLE DRY
K772208 · Precision Dynamics Corp.
JTW · System, Transport, Aerobic · 8d
Cleared Dec 09, 1977
CULTURE COLLEC. TRANS. SYS., DOUBLE WET
K772210 · Precision Dynamics Corp.
JTW · System, Transport, Aerobic · 8d
Cleared Nov 22, 1977
TRYPSIN 1%
K771955 · Flow Laboratories, Inc.
IBG · Trypsin · 36d
Cleared Nov 17, 1977
NON-FERMENTER SYSTEM
K772112 · Corning Medical & Scientific
JSW · Kit, Identification, Glucose Nonfermenter · 10d
Cleared Oct 28, 1977
UREAPLASMA DIFFERENTIAL BASAL AGAR MED.
K771686 · Gibco Laboratories Life Technologies, Inc.
JSH · Culture Media, Non-selective And Differential · 52d
Cleared Oct 28, 1977
HUMAN O BUFFER
K771956 · Flow Laboratories, Inc.
GOK · Antisera, Hai (including Hai Control), Rubella · 11d
Cleared Oct 28, 1977
RUBELLA HEMAGGLUTINATION REAGENT KIT
K771957 · Flow Laboratories, Inc.
GOK · Antisera, Hai (including Hai Control), Rubella · 11d
Cleared Oct 25, 1977
MARTIN LEWIS AGAR (JEMBEC)
K771870 · Granite Diagnostics, Inc.
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 21d
Cleared Oct 25, 1977
MARTIN LEWIS AGAR (PLATE)
K771871 · Granite Diagnostics, Inc.
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 21d
Cleared Oct 25, 1977
MARTIN LEWIS TRANSGROW
K771872 · Granite Diagnostics, Inc.
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 21d
Cleared Oct 18, 1977
RUBA-NOST TEST KITS
K771796 · Behring Diagnostics, Inc.
GOL · Antigen, Ha (including Ha Control), Rubella · 25d
Cleared Sep 02, 1977
PHADEBAS RAST PENICLLOYL G/V TEST
K771578 · Pharmacia, Inc.
DHB · System, Test, Radioallergosorbent (rast) Immunological · 15d
Cleared Sep 02, 1977
FLUORESCENT ANTI. ANTI-HUMAN C3
K771583 · Burroughs Wellcome Co.
DAC · Complement C3b Activator, Antigen, Antiserum, Control · 15d
Cleared Sep 02, 1977
API 20A
K771616 · Analytical Products, Inc.
JSP · Kit, Anaerobic Identification · 9d
Cleared Aug 30, 1977
LAS-R RHEUMATOID FACTOR TEST
K771552 · Hyland Therapeutic Div., Travenol Laboratories
DHR · System, Test, Rheumatoid Factor · 18d
Cleared Aug 03, 1977
API 20C
K771008 · Analytical Products, Inc.
JXB · Kit, Identification, Yeast · 61d
Cleared Aug 03, 1977
ANTISERA TO HUMAN FAB FRAGMENT
K771242 · Kent Laboratories, Inc.
DDR · Myoglobin, Antigen, Antiserum, Control · 23d

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