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
3961–3984 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 22, 1988
ORTHO* SYPHILIS-M ANTIBODY ELISA TEST
K883938 · LIP
Ortho Diagnostic Systems, Inc.
Microbiology · 94d
Cleared Dec 22, 1988
ORTHO* SYPHILIS-G ANTIBODY ELISA TEST
K883939 · LIP
Ortho Diagnostic Systems, Inc.
Microbiology · 94d
Cleared Dec 22, 1988
GROUP A STREP, BETA-STREP
K884750 · GTZ
Ampcor, Inc.
Microbiology · 38d
Cleared Dec 16, 1988
CHLAMYDIAZYME/COMMANDER INSTRUMENTATION
K885006 · LJC
Abbott Laboratories
Microbiology · 14d
Cleared Dec 15, 1988
EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST
K882440 · LLM
Zeus Scientific, Inc.
Microbiology · 184d
Cleared Dec 15, 1988
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES
K882447 · LSE
Zeus Scientific, Inc.
Microbiology · 184d
Cleared Dec 13, 1988
LYME DISEASE IFA (IGG)
K883487 · LSR
Hillcrest Biologicals
Microbiology · 119d
Cleared Dec 13, 1988
WASHER 500 MICROELISA SYSTEM
K884695 · JTC
Organon Teknika Corp.
Microbiology · 34d
Cleared Dec 08, 1988
MODIFIED IDEIA CHLAMYDIA TEST
K880799 · LJC
Boots-Celltech Diagnostics, Inc.
Microbiology · 283d
Cleared Dec 05, 1988
INDIRECT FLUORESCENT ASSAY FOR (HCMV)
K882835 · GQH
Stellar Bio Systems, Inc.
Microbiology · 150d
Cleared Dec 05, 1988
RUBEOLA TEST
K884004 · GRE
Gull Laboratories, Inc.
Microbiology · 75d
Cleared Dec 05, 1988
MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT.
K884761 · GQN
Difco Laboratories, Inc.
Microbiology · 21d
Cleared Nov 30, 1988
PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED
K884517 · LJC
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 34d
Cleared Nov 22, 1988
INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION
K884191 · GNX
Baxter Diagnostics, Inc.
Microbiology · 47d
Cleared Nov 22, 1988
RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION
K884192 · LKT
Baxter Diagnostics, Inc.
Microbiology · 47d
Cleared Nov 22, 1988
PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT
K884193 · GQS
Baxter Diagnostics, Inc.
Microbiology · 47d
Cleared Nov 22, 1988
PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT
K884194 · GQS
Baxter Diagnostics, Inc.
Microbiology · 47d
Cleared Nov 22, 1988
MODIFICATION MIC/API UNISCEPT(R)
K884509 · JWY
Analytical Products, Inc.
Microbiology · 26d
Cleared Nov 22, 1988
MODIFICATION MICRO-MIC
K884510 · JWY
Analytical Products, Inc.
Microbiology · 26d
Cleared Nov 10, 1988
KODAK SURECELL CHLAMYDIA TEST KIT
K882923 · LJC
Eastman Kodak Company
Microbiology · 120d
Cleared Nov 03, 1988
NOVAPATH SPECIMEN COLLECTION KIT
K884342 · LIO
Bio-Rad
Microbiology · 20d
Cleared Nov 01, 1988
PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM
K884357 · KOT
Precision Dynamics Corp.
Microbiology · 15d
Cleared Oct 31, 1988
DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT
K882629 · GQG
Bd Becton Dickinson Vacutainer...
Microbiology · 126d
Cleared Oct 31, 1988
FIAGEN RUBELLA IGG
K883182 · LFX
Cyberfluor, Inc.
Microbiology · 95d