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
5651–5675 of 5945
Cleared Jan 17, 1980
PARA-PAK (C&S)
K792712 · Meridian Diagnostics, Inc.
JSM · Culture Media, Non-propagating Transport · 21d
Cleared Jan 17, 1980
COCCIDIOIDES IMMITIS, ANTISERUM POS.
K792717 · Meridian Diagnostics, Inc.
GMH · Antiserum, Positive Control, Coccidioides Immitis · 21d
Cleared Jan 17, 1980
HISTOPLASMA CAPSULATUM, ANTISERUM
K792718 · Meridian Diagnostics, Inc.
GMK · Antiserum, Positive Control, Histoplasma Capsulatum · 21d
Cleared Jan 11, 1980
ENTERIC-TEK
K792058 · Flow Laboratories, Inc.
JSS · Kit, Identification, Enterobacteriaceae · 88d
Cleared Jan 09, 1980
TODD HEWITT BROTH
K792423 · Isle Media and Sterile Products, Inc.
JSG · Culture Media, Non-selective And Non-differential · 43d
Cleared Dec 31, 1979
SIM MEDIUM
K792420 · Isle Media and Sterile Products, Inc.
JSE · Culture Media, Multiple Biochemical Test · 34d
Cleared Dec 31, 1979
DECARBOXYLASE BROTH BASE WITH OR WITH-
K792421 · Isle Media and Sterile Products, Inc.
JSH · Culture Media, Non-selective And Differential · 34d
Cleared Dec 31, 1979
TETRATHIONATE BROTH BASE
K792422 · Isle Media and Sterile Products, Inc.
JSJ · Culture Media, Selective And Non-differential · 34d
Cleared Dec 31, 1979
VOGEL-JOHNSON AGAR
K792542 · Isle Media and Sterile Products, Inc.
JSH · Culture Media, Non-selective And Differential · 21d
Cleared Dec 31, 1979
PHENYLETHANOL AGAR
K792593 · Isle Media and Sterile Products, Inc.
JSJ · Culture Media, Selective And Non-differential · 14d
Cleared Dec 31, 1979
TRYPTIC SOY AGAR W/LECITHIN & POLYSRBTE.
K792594 · Isle Media and Sterile Products, Inc.
JSG · Culture Media, Non-selective And Non-differential · 14d
Cleared Dec 31, 1979
SF MEDIUM (SF BROTH, STREPTOCOCCUS
K792595 · Isle Media and Sterile Products, Inc.
JSJ · Culture Media, Selective And Non-differential · 14d
Cleared Dec 31, 1979
TRYPTIC SOY AGAR W/PHENYLETHANOL &
K792596 · Isle Media and Sterile Products, Inc.
JSJ · Culture Media, Selective And Non-differential · 14d
Cleared Dec 27, 1979
CHOCOLATE TELLURITE AGAR
K792424 · Isle Media and Sterile Products, Inc.
JSI · Culture Media, Selective And Differential · 30d
Cleared Dec 27, 1979
DECARBOXYLASE MOELLER BASE WITH OR WITH-
K792425 · Isle Media and Sterile Products, Inc.
JSE · Culture Media, Multiple Biochemical Test · 30d
Cleared Dec 27, 1979
TRYPTOSE BLOOD AGAR BASE & TRYPTOSE
K792543 · Isle Media and Sterile Products, Inc.
JSG · Culture Media, Non-selective And Non-differential · 17d
Cleared Dec 27, 1979
LYSINE IRON AGAR
K792544 · Isle Media and Sterile Products, Inc.
JSH · Culture Media, Non-selective And Differential · 17d
Cleared Dec 27, 1979
BACTEC BACTERIAL DETECTION SYSTEM
K792575 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTA · Monitor, Microbial Growth · 14d
Cleared Dec 19, 1979
AMS YEAST BIOCHEMICAL CARD
K792231 · Vitek Systems, Inc.
JXB · Kit, Identification, Yeast · 44d
Cleared Dec 19, 1979
BRAIN HEART INFUSION W/PABA, O.1%,
K792276 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSG · Culture Media, Non-selective And Non-differential · 36d
Cleared Dec 19, 1979
MR-VP MEDIUM
K792286 · Isle Media and Sterile Products, Inc.
JSH · Culture Media, Non-selective And Differential · 36d
Cleared Dec 19, 1979
KF STREPTOCOCCUS AGAR
K792287 · Isle Media and Sterile Products, Inc.
JSJ · Culture Media, Selective And Non-differential · 36d
Cleared Dec 19, 1979
TRYPTONE BROTH (TRYPTOPHANE BROTH)
K792288 · Isle Media and Sterile Products, Inc.
JSH · Culture Media, Non-selective And Differential · 36d
Cleared Dec 07, 1979
COAGULASE PLASMA
K792235 · Remel Co.
JTL · Plasma, Coagulase, Human, Horse And Rabbit · 31d
Cleared Nov 16, 1979
ROTAZYME
K791746 · Abbott Laboratories
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 67d

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