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
1081–1104 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Aug 26, 2013
PRODESSE PROFAST+ ASSAY
K132237 · OQW
Gen-Probe Prodesse, Inc.
Microbiology · 39d
Cleared Aug 23, 2013
BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY
K130268 · OUY
Becton, Dickinson & CO
Microbiology · 200d
Cleared Aug 22, 2013
SAS FLUALERT A & B, SAS INFLUENZA A TEST
K132352 · GNX
Sa Scientific , Ltd.
Microbiology · 24d
Cleared Aug 21, 2013
IMDX FLU A/B AND RSV FOR ABBOTT M2000
K131584 · OCC
Intelligent Medical Devices, Inc.
Microbiology · 82d
Not Cleared Aug 21, 2013
VITEK MS
DEN130013 · PEX
bioMerieux, Inc.
Microbiology · 231d
Cleared Aug 14, 2013
PRO HMPV+ ASSAY
K132200 · OEM
Gen-Probe Prodesse, Inc.
Microbiology · 29d
Cleared Aug 14, 2013
PROADENO+ ASSAY
K132159 · OCC
Gen-Probe Prodesse, Inc.
Microbiology · 33d
Cleared CT Aug 13, 2013
SOFIA(R) RSV FIA
K130398 · GQG
Quidel Corp.
Microbiology · 175d
Cleared Aug 09, 2013
PRODESSE PROFLU+ ASSAY
K132129 · OCC
Gen-Probe Prodesse, Inc.
Microbiology · 30d
Cleared Aug 09, 2013
LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II
K131441 · LGD
DiaSorin, Inc.
Microbiology · 81d
Cleared Aug 07, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132259 · PSZ
Becton, Dickinson and Company
Microbiology · 19d
Cleared Aug 07, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132256 · PSZ
Becton, Dickinson and Company
Microbiology · 19d
Cleared Aug 05, 2013
JBAIDS ANTHRAX DETECTION KIT
K131930 · NHT
Biofire Diagnostics, Inc.
Microbiology · 39d
Cleared Jul 31, 2013
JBAIDS TULAREMIA DETECTION KIT
K131936 · OEH
Biofire Diagnostics, Inc.
Microbiology · 34d
Cleared Jul 31, 2013
JBAIDS PLAGUE DETECTION KIT
K131729 · OIH
Biofire Diagnostics, Inc.
Microbiology · 49d
Not Cleared Jul 25, 2013
XPERT MTB/RIF ASSAY
DEN130032 · PEU
Cepheid
Microbiology · 44d
Cleared Jul 21, 2013
GRAM-NEGATIVE QUICKFISH BC
K123418 · JSS
Advandx, Inc.
Microbiology · 257d
Cleared Jul 17, 2013
IMDX VANR FOR ABBOTT M2000
K123753 · NIJ
Intelligent Medical Devices, Inc.
Microbiology · 223d
Cleared Jul 12, 2013
REMEL XPECT FLU A&B
K131804 · GNX
Remel, Inc.
Microbiology · 23d
Cleared Jul 10, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)
K131331 · LON
Becton, Dickinson & CO
Microbiology · 62d
Cleared Jul 05, 2013
SOFIA INFLUENZA A+B FIA
K131606 · GNX
Quidel Corp.
Microbiology · 32d
Cleared Jul 05, 2013
QUICK VUE INFLUENZA
K131599 · GNX
Quidel Corporation
Microbiology · 32d
Cleared Jun 28, 2013
QUICKVUE INFLUENZA A+B
K131619 · GNX
Quidel Corp.
Microbiology · 25d
Cleared Jun 27, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML)
K123404 · LON
Becton, Dickinson & CO
Microbiology · 234d