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
3937–3960 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 07, 1989
ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST
K883937 · LGD
Ortho Diagnostic Systems, Inc.
Microbiology · 141d
Cleared Feb 07, 1989
BACTIGEN(R) MENINGITIDIS PANEL
K884965 · GWC
Armkel, LLC
Microbiology · 69d
Cleared Feb 07, 1989
BACTIGEN(R) S. PNEUMONIAE
K884966 · GWC
Armkel, LLC
Microbiology · 69d
Cleared Feb 07, 1989
BACTIGEN(R) H. INFLUENZAE TYPE B
K884967 · GRP
Armkel, LLC
Microbiology · 69d
Cleared Feb 07, 1989
BACTIGEN(R) GROUP B STREPTOCOCCUS TEST
K885003 · GTZ
Armkel, LLC
Microbiology · 68d
Cleared Feb 07, 1989
BACTIGEN(R) N. MENINGITIDIS
K885004 · GTJ
Armkel, LLC
Microbiology · 68d
Cleared Feb 07, 1989
MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA
K890154 · LGD
Labsystems, Inc.
Microbiology · 26d
Cleared Feb 07, 1989
DIFCO DIRECTOR INOCULATION SYSTEM
K890339 · LIE
Difco Laboratories, Inc.
Microbiology · 15d
Cleared Feb 03, 1989
BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE
K883776 · LKI
Btc Corp.
Microbiology · 150d
Cleared Feb 03, 1989
ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT
K884026 · GNA
Oxoid U.S.A., Inc.
Microbiology · 133d
Cleared Feb 03, 1989
PF TEST
K884513 · GMZ
Medi-Tech, Inc.
Microbiology · 99d
Cleared Feb 03, 1989
IMMUNODOT TORCH TEST RUBELLA
K884898 · LFX
General Biometrics, Inc.
Microbiology · 72d
Cleared Feb 03, 1989
MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KIT
K890091 · LFX
Labsystems, Inc.
Microbiology · 29d
Cleared Feb 02, 1989
ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY
K884617 · LFX
Ortho Diagnostic Systems, Inc.
Microbiology · 90d
Cleared Feb 02, 1989
IMMUNODOT RUBELLA TEST
K885082 · LFX
General Biometrics, Inc.
Microbiology · 55d
Cleared Jan 31, 1989
RUBENOSTIKA(TM) IGM MICROELISA SYSTEM
K882999 · LFX
Organon Teknika Corp.
Microbiology · 197d
Cleared Jan 31, 1989
QUIK-DOT ANTISTREPTOLYSIN-O
K890025 · GTQ
Ampcor, Inc.
Microbiology · 27d
Cleared Jan 24, 1989
TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA
K883720 · LGD
Lmd Laboratories
Microbiology · 146d
Cleared Jan 24, 1989
ROTACUBE
K884017 · LIQ
Difco Laboratories, Inc.
Microbiology · 124d
Cleared Jan 24, 1989
EBV-VCA ANTIBODY (IGG)
K884591 · GNP
Hillcrest Biologicals
Microbiology · 82d
Cleared Jan 13, 1989
LYME FAST TEST
K883544 · LSR
3M Company
Microbiology · 147d
Cleared Jan 13, 1989
FITC MURINE MONOCLONAL ANTI-RSV IGG
K884516 · GQG
Whittaker Bioproducts, Inc.
Microbiology · 78d
Cleared Jan 04, 1989
ORTHO* ROTAVIRUS ANTIGEN ELISA TEST
K883935 · LIQ
Ortho Diagnostic Systems, Inc.
Microbiology · 107d
Cleared Jan 04, 1989
ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST
K883940 · LIQ
Ortho Diagnostic Systems, Inc.
Microbiology · 107d