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
1705–1728 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 20, 2004
WEST NILE VIRUS IGG INDIRECT ELISA
K041068 · NOP
Panbio Limited
Microbiology · 177d
Cleared Oct 07, 2004
PASCO MIC AND MIC/ID PANELS
K042331 · JWY
Pasco Laboratories, Inc.
Microbiology · 38d
Cleared Sep 27, 2004
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
K042303 · JJX
Ortho-Clinical Diagnostics
Microbiology · 33d
Cleared Sep 14, 2004
VITEK 2 GRAM NEGATIVE ERTAPENEM
K041982 · LON
bioMerieux, Inc.
Microbiology · 53d
Cleared Sep 14, 2004
DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K042157 · JTN
Oxoid , Ltd.
Microbiology · 35d
Cleared Aug 20, 2004
IMMUNOCARD TOXINS A & B, MODEL 712050
K041003 · LLH
Meridian Bioscience, Inc.
Microbiology · 123d
Cleared Aug 13, 2004
IMMUNOCARD STAT! RSV MODEL #750630
K041445 · GQG
Meridian Bioscience, Inc.
Microbiology · 73d
Cleared Aug 12, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/ML
K041572 · LON
Becton, Dickinson and Co.
Microbiology · 59d
Cleared Aug 10, 2004
BINAXNOW INFLUENZA A & B TEST
K041049 · PSZ
Binax, Inc.
Microbiology · 110d
Cleared Aug 10, 2004
WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M
K041231 · NOP
Panbio Limited
Microbiology · 92d
Cleared Aug 03, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE
K041384 · LON
Becton, Dickinson & CO
Microbiology · 70d
Cleared Aug 03, 2004
PASCO MIC AND MIC/ID PANELS
K041776 · JWY
Pasco Laboratories, Inc.
Microbiology · 33d
Cleared Jul 27, 2004
ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING
K040560 · NGZ
Ab Biodisk
Microbiology · 146d
Cleared Jul 27, 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE...
K041534 · JWY
Trek Diagnostic Systems, Ltd.
Microbiology · 49d
Cleared Jul 22, 2004
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS
K041150 · LRG
Dade Behring, Inc.
Microbiology · 80d
Cleared Jul 22, 2004
SAS INFLUENZA B TEST
K041439 · PSZ
Sa Scientific, Inc.
Microbiology · 51d
Cleared Jul 22, 2004
SAS INFLUENZA A TEST
K041441 · PSZ
Sa Scientific, Inc.
Microbiology · 51d
Cleared Jul 15, 2004
POCONE INFRARED SPECTROPHOTOMETER
K041148 · MSQ
Otsuka Pharmaceutical Co., Ltd.
Microbiology · 73d
Cleared Jul 13, 2004
CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT
K033105 · MXJ
Trinity Biotech USA
Microbiology · 287d
Cleared Jul 13, 2004
CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT
K033106 · MYF
Trinity Biotech USA
Microbiology · 287d
Cleared Jun 30, 2004
WEST NILE VIRUS IGM CAPTURE ELISA
K040854 · NOP
Focus Technologies, Inc.
Microbiology · 90d
Cleared Jun 08, 2004
VITEK 2 ESBL TEST
K040845 · LON
bioMerieux, Inc.
Microbiology · 68d
Cleared Jun 07, 2004
PASCO MIC AND MIC/ID PANELS
K041214 · JWY
Pasco Laboratories, Inc.
Microbiology · 28d
Cleared Jun 03, 2004
QUICKELISA ANTHRAX-PA KIT
K040407 · NRL
Immunetics, Inc.
Microbiology · 107d