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
1417–1440 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared Dec 05, 2008
ELECSYS RUBELLA IGG IMMUNOASSAY
K072617 · LFX
Roche Diagnostics Corp.
Microbiology · 445d
Cleared Dec 05, 2008
LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV
K082049 · LOL
DiaSorin, Inc.
Microbiology · 140d
Cleared Dec 05, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML
K082913 · LON
Becton, Dickinson & CO
Microbiology · 66d
Cleared Nov 21, 2008
DIASORIN LIASON RUBELLA IGG ASSAY
K073390 · LFX
DiaSorin, Inc.
Microbiology · 354d
Cleared Nov 20, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE...
K082538 · LON
Becton, Dickinson & CO
Microbiology · 79d
Cleared Nov 18, 2008
LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG
K081685 · MXJ
DiaSorin, Inc.
Microbiology · 154d
Cleared Nov 10, 2008
LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG
K081687 · MYF
DiaSorin, Inc.
Microbiology · 146d
Cleared Nov 07, 2008
PRO HMPV+ ASSAY
K082688 · OEM
Prodesse, Inc.
Microbiology · 53d
Cleared Nov 03, 2008
LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM
K082050 · LOL
DiaSorin, Inc.
Microbiology · 108d
Cleared Oct 24, 2008
SENSITITRE VIZION
K081520 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 147d
Cleared Oct 06, 2008
FLUCONAZOLE 25UG BBL SENSI-DISC
K082271 · JTN
Becton, Dickinson & CO
Microbiology · 56d
Cleared Oct 06, 2008
BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A
K082661 · GTY
Princeton BioMeditech Corp.
Microbiology · 24d
Cleared Oct 02, 2008
VORICONAZOLE 1UG BBL SENSI-DISC
K082272 · JTN
Becton, Dickinson & CO
Microbiology · 52d
Cleared Sep 30, 2008
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL
K080570 · NXD
Centers For Disease Control and...
Microbiology · 214d