FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
1177–1200 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared Sep 27, 2011
VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN
K112129 · LON
bioMerieux, Inc.
Microbiology · 63d
Cleared Sep 22, 2011
SENSITITRE OPTIREAD
K110583 · LRG
Trek Diagnostic Systems, Ltd.
Microbiology · 205d
Cleared Sep 15, 2011
VITEK 2 STRPTOCOCCUS AMPICILLIN
K112075 · LON
bioMerieux, Inc.
Microbiology · 57d
Cleared Sep 13, 2011
JBAIDS INFLUENZA A&B DETECTION KIT
K111775 · OCC
U.S. Army Medical Material...
Microbiology · 82d