Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Microbiology ×
7,095 results
1729–1752 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Nov 19, 2004
WEST NILE DETECT IGM ELISA
K041817 · NOP
Inbios Intl., Inc.
Microbiology · 136d
Cleared Nov 19, 2004
ETEST FOR GEMIFLOXACIN
K042390 · JWY
Ab Biodisk
Microbiology · 78d
Cleared Nov 15, 2004
XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B
K041951 · LLH
Remel, Inc.
Microbiology · 118d
Cleared Oct 22, 2004
IDI-MRSA ASSAY
K042357 · NQX
Infectio Diagnostic (I.D.I.), Inc.
Microbiology · 52d
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