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
5943 Microbiology devices
4776–4800 of 5943
Cleared Mar 26, 1984
COLUMBIA AGAR W/COLISTIN, NALADIXIC
K841139 · Anaerobe Systems
JSJ · Culture Media, Selective And Non-differential · 10d
Cleared Mar 26, 1984
PHENYLETHYL ALCOHOL BLOOD AGAR
K841140 · Anaerobe Systems
JSJ · Culture Media, Selective And Non-differential · 10d
Cleared Mar 26, 1984
MACCONKEY AGAR
K841141 · Anaerobe Systems
JSI · Culture Media, Selective And Differential · 10d
Cleared Mar 26, 1984
COLUMBIA AGAR W/5% SHEEP BLOOD
K841143 · Anaerobe Systems
JSG · Culture Media, Non-selective And Non-differential · 10d
Cleared Mar 26, 1984
CHOCOLATE AGAR W/COFACTOR
K841144 · Anaerobe Systems
JSG · Culture Media, Non-selective And Non-differential · 10d
Cleared Mar 23, 1984
CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT
K834115 · Bartels Immunodiagnostic Supplies, Inc.
JSK · Supplement, Culture Media · 115d
Cleared Mar 23, 1984
SDL LISTERIA MONOCYTOGENES CONTROL
K840503 · Scientific Device Laboratory, Inc.
GSI · Antigens, Slide And Tube, All Types, Listeria Monocytogenes · 46d
Cleared Mar 23, 1984
SDL NEISSERIA MENINGITIDES GR. 2
K840504 · Scientific Device Laboratory, Inc.
LSC · Neisseria Controls · 46d
Cleared Mar 23, 1984
SDL NEISSERIA MENNINGITIDIS GR. X
K840505 · Scientific Device Laboratory, Inc.
LSC · Neisseria Controls · 46d
Cleared Mar 23, 1984
NEISSERIA MENINGITIDIS GR. Y
K840507 · Scientific Device Laboratory, Inc.
LSC · Neisseria Controls · 46d
Cleared Mar 23, 1984
NEISSERIA MENINGITIDIS GR. C
K840508 · Scientific Device Laboratory, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 46d
Cleared Mar 23, 1984
NEISSERIA MENINGITIDIS GR. B
K840509 · Scientific Device Laboratory, Inc.
LSC · Neisseria Controls · 46d
Cleared Mar 23, 1984
NEISSERIA MENINGITIDIS GR. A
K840510 · Scientific Device Laboratory, Inc.
LSC · Neisseria Controls · 46d
Cleared Mar 23, 1984
STREPTOCOCCUS GR. D
K840511 · Scientific Device Laboratory, Inc.
GTY · Antigens, All Groups, Streptococcus Spp. · 46d
Cleared Mar 23, 1984
STREPTOCOCCUS PNEUMONIAE CONTROL
K840512 · Scientific Device Laboratory, Inc.
GTY · Antigens, All Groups, Streptococcus Spp. · 46d
Cleared Mar 23, 1984
STREPTOCOCCUS GR. B CONTROL
K840513 · Scientific Device Laboratory, Inc.
GTY · Antigens, All Groups, Streptococcus Spp. · 46d
Cleared Mar 23, 1984
NEISSERIA MENINGITIDIS CONTROL
K840514 · Scientific Device Laboratory, Inc.
LSC · Neisseria Controls · 46d
Cleared Mar 23, 1984
DIFFERENTIATION DISKS SPS
K840804 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 28d
Cleared Mar 23, 1984
MICRODASE
K840819 · Remel Co.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 28d
Cleared Mar 23, 1984
CLOSTRIDIUM DIFFICILE AGAR DEEP &
K840889 · Remel Co.
JSI · Culture Media, Selective And Differential · 25d
Cleared Mar 23, 1984
BUFFERED CYE AGAR DEEP W/SUPPLEMENTS
K840890 · Remel Co.
JSJ · Culture Media, Selective And Non-differential · 25d
Cleared Mar 23, 1984
DIFFERENTIATION DISKS ALA
K840896 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 25d
Cleared Mar 23, 1984
PRESERV TRANSPORT & CULTURE PACK
K840968 · Preventive Diagnostics Corp.
JTW · System, Transport, Aerobic · 17d
Cleared Mar 23, 1984
NIACIN REAGENT STRIP
K840981 · Remel Co.
MJD · Culture Media, Antimycobacteria, Susceptibility Test · 17d
Cleared Mar 23, 1984
PRESERV CARY BLAIR TRANSPORT PACK
K840990 · Preventive Diagnostics Corp.
JTW · System, Transport, Aerobic · 16d

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All categories 5943 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