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
1465–1488 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared Jan 14, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML
K073433 · LON
Becton, Dickinson & CO
Microbiology · 39d
Cleared Jan 04, 2008
PROFLU+ ASSAY
K073029 · OCC
Prodesse, Inc.
Microbiology · 67d
Not Cleared Jan 03, 2008
ID-TAG RESPIRATORY VIRAL PANEL
DEN070013 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 30d
Cleared Dec 21, 2007
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
K072138 · LLH
bioMerieux, Inc.
Microbiology · 141d
Cleared Dec 20, 2007
BD GENEOHM STAPHSR ASSAY
K071026 · NQX
Bd Diagnostics (Geneohm Sciences...
Microbiology · 253d
Cleared Dec 20, 2007
JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123
K072631 · NHT
Idaho Technology, Inc.
Microbiology · 93d
Cleared Dec 19, 2007
JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124
K072547 · OEH
Idaho Technology, Inc.
Microbiology · 100d
Cleared Dec 10, 2007
VITEK 2 GRAM NEGATIVE PIPERACILLIN
K073083 · LON
bioMerieux, Inc.
Microbiology · 39d
Cleared Nov 26, 2007
RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE
K072827 · MJE
Remel, Inc.
Microbiology · 54d
Cleared Nov 20, 2007
BBL CHROMAGAR 0157
K070691 · JSI
Becton, Dickinson & CO
Microbiology · 252d
Cleared Nov 16, 2007
VITEK 2 GRAM POSITIVE TIGECYCLINE
K072695 · LON
bioMerieux, Inc.
Microbiology · 53d
Cleared Nov 15, 2007
TRU FLU
K071657 · PSZ
Meridian Bioscience, Inc.
Microbiology · 150d
Cleared Oct 24, 2007
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING...
K070265 · GQN
Diagnostic Hybrids, Inc.
Microbiology · 268d
Cleared Oct 18, 2007
TRU RSV
K071101 · GOG
Meridian Bioscience, Inc.
Microbiology · 182d