FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,061 results
1417–1440 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jul 10, 2008
ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT
K080739 · MKZ
Abbott Molecular, Inc.
Microbiology · 115d
Cleared Jun 26, 2008
PLATELIA LYME IGM
K081362 · LSR
Bio-Rad
Microbiology · 42d
Cleared Jun 25, 2008
XTAG RESPIRATORY VIRAL PANEL
K081483 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 28d
Cleared Jun 23, 2008
NUCLISENS EASYQ ENTEROVIRUS SYSTEM
K063261 · OAI
bioMerieux, Inc.
Microbiology · 602d
Cleared Jun 13, 2008
D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT
K081164 · LIN
Diagnostic Hybrids, Inc.
Microbiology · 50d
Cleared Jun 13, 2008
MRSASELECT - EXTENDED INCUBATION
K081212 · JSO
Bio-Rad
Microbiology · 45d
Cleared Jun 11, 2008
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
K080931 · LLH
bioMerieux, Inc.
Microbiology · 70d
Cleared Jun 09, 2008
ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG
K073501 · LGD
Roche Diagnostics Corp.
Microbiology · 179d
Cleared May 30, 2008
ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM
K072178 · MXJ
Zeus Scientific, Inc.
Microbiology · 298d
Cleared May 23, 2008
ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC
K080869 · LGD
Beckman Coulter, Inc.
Microbiology · 53d
Cleared May 12, 2008
DORIPENEM 10UG BBL SENSI-DISC
K080998 · JTN
Becton, Dickinson & CO
Microbiology · 35d
Cleared May 08, 2008
PLATELIA LYME IGG ASSAY
K080012 · LSR
Bio-Rad
Microbiology · 126d
Cleared May 02, 2008
MODIFICATION TO PROFLU+ ASSAY
K081030 · OCC
Prodesse, Inc.
Microbiology · 21d
Cleared Apr 30, 2008
VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE
K080201 · LON
bioMerieux, Inc.
Microbiology · 93d
Cleared Apr 16, 2008
RAMP INFLUENZA A/B ASSAY
K071591 · PSZ
Response Biomedical Corp.
Microbiology · 310d
Cleared Mar 31, 2008
B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM
K070310 · NTM
Brahms Aktiengesellschaft
Microbiology · 424d
Cleared Mar 20, 2008
SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE
K073653 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 85d
Cleared Mar 13, 2008
SENSITITRE 18-24 SUSCEPTIBILITY PLATE
K073558 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 85d
Cleared Mar 05, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML)...
K073589 · LON
Becton, Dickinson & CO
Microbiology · 76d
Cleared Feb 28, 2008
SPECTRA MRSA
K073027 · JSO
Thermo Fisher Scientific
Microbiology · 125d
Cleared Feb 28, 2008
VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM
K080107 · LON
bioMerieux, Inc.
Microbiology · 44d
Cleared Jan 29, 2008
HARDYDISK AST DORIPENEM 10 UG
K080019 · JTN
Hardy Diagnostics
Microbiology · 26d
Cleared Jan 23, 2008
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
K073406 · LON
bioMerieux, Inc.
Microbiology · 50d
Cleared Jan 22, 2008
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K073424 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 48d