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
3505–3528 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 17, 1991
MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN
K905306 · GRC
Virion (U.S.), Inc.
Microbiology · 201d
Cleared Jun 17, 1991
QM300 CALIBRATOR G PACK
K910885 · GTQ
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 105d
Cleared Jun 17, 1991
QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK
K910886 · GTQ
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 105d
Cleared Jun 17, 1991
QM300 CONTROL G PACK
K910887 · GTQ
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 105d
Cleared Jun 17, 1991
HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT
K911345 · GQN
Diagnostic Hybrids, Inc.
Microbiology · 82d
Cleared Jun 11, 1991
VZVSCAN(TM) LATEX AGGUTINATION TEST
K912239 · GQW
Bd Becton Dickinson Vacutainer...
Microbiology · 21d
Cleared Jun 10, 1991
EIA FOR DETECTION OF ANTIBODIES H. PYLORI
K905409 · LYR
E-Z-Em, Inc.
Microbiology · 189d
Cleared Jun 10, 1991
LYME DISEASE MICROASSAY
K910899 · LSR
Diamedix Corp.
Microbiology · 105d
Cleared Jun 10, 1991
TURBIDOMETRIC STANDARD
K911059 · LIE
Scientific Device Laboratory, Inc.
Microbiology · 91d
Cleared Jun 10, 1991
LYME IGM MICROASSAY
K911330 · LSR
Diamedix Corp.
Microbiology · 77d
Cleared Jun 10, 1991
EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST
K911569 · LLM
Ortho Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Jun 10, 1991
EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST
K911570 · MCD
Ortho Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Jun 10, 1991
EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST
K911571 · MCD
Ortho Diagnostic Systems, Inc.
Microbiology · 63d
Cleared May 28, 1991
HSV-2 IGG ELISA TEST
K910952 · LGC
Gull Laboratories, Inc.
Microbiology · 82d
Cleared May 28, 1991
HSV-2 IGM ELISA TEST
K910953 · LGC
Gull Laboratories, Inc.
Microbiology · 82d
Cleared May 28, 1991
HSV-1 IGG ELISA TEST
K910954 · LGC
Gull Laboratories, Inc.
Microbiology · 83d
Cleared May 28, 1991
HSV-1 IGM ELISA TEST
K910955 · LGC
Gull Laboratories, Inc.
Microbiology · 83d
Cleared May 21, 1991
TARGET ASO TEST
K910073 · GTQ
Texas Immunology, Inc.
Microbiology · 132d
Cleared May 20, 1991
ENZYGNOST ANTI-CMV/IGG + IGM
K901485 · LFZ
Behring Diagnostics, Inc.
Microbiology · 417d
Cleared May 15, 1991
ANTIMICROBIAL SUSCEPT. TEST PANEL NITROFURANTOIN
K911558 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 37d
Cleared May 10, 1991
BACTI-SWAB
K910180 · JSM
Remel Co.
Microbiology · 115d
Cleared May 10, 1991
BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST
K911145 · LSR
Medical Diagnostic Technologies, Inc.
Microbiology · 70d
Cleared May 08, 1991
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (IMIPENEM)
K911389 · JWY
Alamar
Microbiology · 40d
Cleared May 08, 1991
ANTIMICROBIAL SUSCEPT. TEST PANEL(TRIMETHOPRIM)
K911390 · JWY
Alamar
Microbiology · 40d