FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
3265–3288 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 24, 1992
TRANSYSTEM AMIES W/O CHARCOAL
K924329 · LIO
Pro-Lab Diagnostics
Microbiology · 119d
Cleared Dec 24, 1992
TRANSYSTEM AMIES WITH CHARCOAL
K924330 · LIO
Pro-Lab Diagnostics
Microbiology · 119d
Cleared Dec 24, 1992
TRANSYSTEM LIQUID STUART MEDIUM
K924331 · LIO
Pro-Lab Diagnostics
Microbiology · 119d
Cleared Dec 15, 1992
BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA
K922333 · LGC
Baxter Diagnostics, Inc.
Microbiology · 216d
Cleared Dec 15, 1992
BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA
K922334 · LGC
Baxter Diagnostics, Inc.
Microbiology · 216d
Cleared Dec 11, 1992
DRIED GRAM-NEGATIVE AND POSITIVE MIC/COMBO PANELS
K922458 · JWY
Baxter Healthcare Corp
Microbiology · 199d
Cleared Dec 07, 1992
VIGIL II
K920845 · DCK
Beckman Instruments, Inc.
Microbiology · 286d
Cleared Dec 07, 1992
CHOLERASCREEN
K922432 · GSQ
New Horizons Diagnostics Co.
Microbiology · 199d
Cleared Dec 07, 1992
ACCUTEX ASO LATEX TEST
K924247 · GTQ
J.S. Medical Assoc.
Microbiology · 105d
Cleared Dec 03, 1992
ARBOVIRUS IGG IFA TEST
K913617 · GQC
Hillcrest Biologicals
Microbiology · 478d
Cleared Dec 03, 1992
ARBOVIRUS IGM IFA TEST
K913618 · GQC
Hillcrest Biologicals
Microbiology · 478d
Cleared Dec 03, 1992
API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC
K923684 · JWY
Analytical Products, Inc.
Microbiology · 133d
Cleared Dec 03, 1992
REMEL ENOXACIN 10 MCG SUSCEPTIBILITY DISK
K925060 · JTN
Remel Co.
Microbiology · 58d
Cleared Nov 30, 1992
ANTIMICROBIAL SUSCEPTIBILITY TEST
K924500 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 87d
Cleared Nov 30, 1992
REMEL CEFACLOR 30MCG SUSCEPTIBILITY DISK
K924846 · JTN
Remel Co.
Microbiology · 63d
Cleared Nov 02, 1992
NIZYME TEST KIT
K923566 · JSX
Remel Co.
Microbiology · 108d
Cleared Nov 02, 1992
CEFPODOXIME 10 MCG, SENSI DISC
K924797 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 39d
Cleared Oct 26, 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K923122 · LFY
Biomerieux Vitek, Inc.
Microbiology · 122d
Cleared Oct 26, 1992
REMEL LOMEFLOXACIN 10 MCG SUSCEPTIBILITY DISK
K924765 · JTN
Remel Co.
Microbiology · 33d
Cleared Oct 26, 1992
REMEL OFLOXACIN 5MCG SUSCEPTIBILITY DISK
K924766 · JTN
Remel Co.
Microbiology · 33d
Cleared Oct 21, 1992
Q FEVER IGG IFA TEST
K913906 · GPJ
Hillcrest Biologicals
Microbiology · 418d
Cleared Oct 21, 1992
Q FEVER IGM IFA TEST
K922374 · GPJ
Hillcrest Biologicals
Microbiology · 154d
Cleared Oct 20, 1992
FUNGI FLUOR KIT
K923349 · LYF
Polysciences, Inc.
Microbiology · 104d
Cleared Oct 19, 1992
MERITEC C. DIFFICILE CONTROLS
K924062 · MCB
Meridian Diagnostics, Inc.
Microbiology · 68d