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
1369–1392 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Apr 01, 2009
LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT
K081527 · GQL
Millipore Corporation
Microbiology · 303d
Cleared Mar 26, 2009
EK/P. AERUGINOSA PNA FISH
K081433 · JSS
Advandx, Inc.
Microbiology · 309d
Cleared Mar 26, 2009
C. DIFF QUIK CHEK COMPLETE
K082499 · LLH
Techlab, Inc.
Microbiology · 209d
Cleared Mar 24, 2009
SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES
K083606 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 109d
Cleared Mar 16, 2009
VITEK 2 GRAM NEGATIVE DORIPENEM
K082346 · LON
bioMerieux, Inc.
Microbiology · 213d
Cleared Mar 06, 2009
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
K081063 · NGZ
Trek Diagnostic Systems, Inc.
Microbiology · 326d
Cleared Mar 06, 2009
D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT
K090073 · OMG
Diagnostic Hybrids, Inc.
Microbiology · 53d
Cleared Feb 23, 2009
BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET
K080008 · OMI
Bio-Rad Laboratories, Inc.
Microbiology · 418d
Cleared Feb 18, 2009
MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32...
K083262 · LTT
Siemens Healthcare Diagnostics
Microbiology · 105d
Cleared Feb 18, 2009
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
K083383 · LON
bioMerieux, Inc.
Microbiology · 93d
Cleared Feb 12, 2009
ELECSYS TOXO IGG CALCHECK
K083655 · JJX
Roche Diagnostics
Microbiology · 64d
Cleared Jan 30, 2009
PREMIER CAMPY, MODEL 618096
K083464 · LQP
Meridian Bioscience, Inc.
Microbiology · 67d
Cleared Jan 29, 2009
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML
K082852 · LON
Becton, Dickinson & CO
Microbiology · 122d
Cleared Jan 15, 2009
REAL-TIME PCR INTERNAL CONTROL 2B SET
K083430 · OLD
Nanogen, Inc.
Microbiology · 57d
Cleared Jan 14, 2009
GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
K081064 · MHI
Ivd Research, Inc.
Microbiology · 275d
Cleared Dec 30, 2008
VIROCULT, MODEL MW950
K082472 · LIO
Medical Wire & Equipment Company...
Microbiology · 124d
Cleared Dec 24, 2008
BD BACTEC Plus Aerobic/F Culture Vials
K083572 · MDB
Becton, Dickinson & CO
Microbiology · 21d
Cleared Dec 23, 2008
VIDAS RUB IGG
K080766 · LFX
bioMerieux, Inc.
Microbiology · 280d
Cleared Dec 23, 2008
D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT
K081746 · GNW
Diagnostic Hybrids, Inc.
Microbiology · 187d
Cleared Dec 23, 2008
D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT
K081928 · LKT
Diagnostic Hybrids, Inc.
Microbiology · 169d
Cleared Dec 19, 2008
E.COLI/P. AERUGINOSA PNA FISH
K081309 · JSS
Advandx, Inc.
Microbiology · 224d
Cleared Dec 19, 2008
BD GENEOHM CDIFF ASSAY
K081920 · LLH
Bd Diagnostics (Geneohm Sciences, Inc.)
Microbiology · 169d
Cleared Dec 11, 2008
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
K081824 · MKZ
Becton, Dickinson & CO
Microbiology · 167d
Cleared Dec 11, 2008
BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY
K081825 · LSL
Becton, Dickinson & CO
Microbiology · 167d