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
1201–1224 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 06, 2012
ARTUS INFL A/B RG RT-PCR KIT
K113323 · OCC
QIAGEN GmbH
Microbiology · 88d
Cleared Feb 01, 2012
GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
K110899 · LYR
Gold Standard Diagnostics
Microbiology · 308d
Cleared Jan 24, 2012
COBAS 4800 CT / NG TEST
K110923 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 298d
Cleared Jan 20, 2012
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS
K112343 · LIP
Siemens Healthcare Diagnostics, Inc.
Microbiology · 158d
Not Cleared Jan 20, 2012
STRATIFY JCV(TM) ANTIBODY
DEN120008 · OYP
Focus Diagnostics, Inc.
Microbiology · 14d
Cleared Dec 22, 2011
QUIDEL MOLECULAR INFLUENZA A + B ASSAY
K112172 · OCC
Quidel Corp.
Microbiology · 147d
Cleared Dec 16, 2011
IMMUNOCARD C. DIFFICILE GDH
K112048 · MCB
Meridian Bioscience, Inc.
Microbiology · 151d
Cleared Dec 16, 2011
VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)
K112424 · NQX
Nanosphere, Inc.
Microbiology · 115d
Cleared Dec 15, 2011
QUIDEL MOLECULAR HMPV ASSAY
K112490 · OEM
Quidel Corp.
Microbiology · 108d
Cleared Dec 05, 2011
ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT
K112125 · NJR
Meridian Bioscience, Inc.
Microbiology · 133d
Cleared Nov 30, 2011
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE
K110106 · LON
bioMerieux, Inc.
Microbiology · 321d
Cleared Nov 16, 2011
VIZION
K112276 · JWY
Trek Diagnostic Systems
Microbiology · 99d
Cleared Nov 09, 2011
ASIMANAGER - AT
K111356 · JQT
Arlington Scientific, Inc.
Microbiology · 177d
Cleared Nov 08, 2011
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES
K111615 · JWY
Trek Diagnostic Systems
Microbiology · 151d
Cleared Oct 28, 2011
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
K112277 · PSZ
Becton, Dickinson and Company
Microbiology · 80d
Cleared Oct 26, 2011
VITEK 2 STREPTOCOCCUS PENICILLIN
K112000 · LON
bioMerieux, Inc.
Microbiology · 105d
Cleared Oct 24, 2011
SOFIA ANALYZER AND INFLUENZA A+B FIA
K112177 · PSZ
Quidel Corp.
Microbiology · 88d
Cleared Oct 21, 2011
VRESELECT CULTURE MEDIUM
K103684 · JSO
Bio-Rad
Microbiology · 308d
Cleared Oct 20, 2011
BD GENEOHM VANR ASSAY
K102416 · NIJ
Bd Diagnostics Science
Microbiology · 422d
Cleared Oct 18, 2011
VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE
K111909 · LON
bioMerieux, Inc.
Microbiology · 105d
Cleared Oct 18, 2011
CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)
K112586 · JTN
Becton, Dickinson and Company (BD)
Microbiology · 42d
Cleared Oct 14, 2011
VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE
K103752 · LON
bioMerieux, Inc.
Microbiology · 295d
Cleared Oct 03, 2011
VITEK 2 STREPTOCOCCUS LEVOFLOXACIN
K112228 · LON
bioMerieux, Inc.
Microbiology · 61d
Cleared Sep 27, 2011
ISOAMP HSV ASSAY
K111951 · OQO
Biohelix Corporation
Microbiology · 81d