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
1369–1392 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 04, 2009
CLEARVIEW ADVANCED STREP A , MODEL 737-430
K091489 · GTY
Binax, Inc.
Microbiology · 107d
Cleared Sep 01, 2009
BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010
K083744 · MJZ
Binax, Inc.
Microbiology · 259d
Cleared Sep 01, 2009
EK/P. AERUGINOSA PNA FISH
K092393 · JSS
Advandx, Inc.
Microbiology · 27d
Cleared Aug 28, 2009
ELVIS HSV ID AND D3 TYPING TEST SYSTEM
K091753 · GQL
Diagnostic Hybrids, Inc.
Microbiology · 73d
Cleared Aug 28, 2009
MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
K092300 · GNW
Diagnostic Hybrids, Inc.
Microbiology · 30d
Cleared Aug 26, 2009
XPECT FLU A & B
K092423 · PSZ
Thermo Fisher Scientific
Microbiology · 19d
Cleared Aug 20, 2009
MODIFICATION TO PROFLU+ ASSAY
K092500 · OCC
Prodesse, Inc.
Microbiology · 6d
Cleared Aug 18, 2009
S. AUREUS PNA FISH
K091827 · NXX
Advandx, Inc.
Microbiology · 60d
Cleared Aug 14, 2009
VITEK 2 GRAM NEGATIVE MEROPENEM
K091899 · LON
bioMerieux, Inc.
Microbiology · 50d
Cleared Aug 12, 2009
MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST
K092223 · PSZ
Binax, Inc.
Microbiology · 20d
Cleared Aug 05, 2009
VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE
K082329 · LSR
Viramed Biotech AG
Microbiology · 356d
Cleared Jul 24, 2009
AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT
K083074 · OAH
Advandx, Inc.
Microbiology · 282d
Cleared Jul 24, 2009
RAMP RSV ASSAY
K091235 · GQG
Response Biomedical Corp.
Microbiology · 88d
Cleared Jul 23, 2009
SAS INFLUENZA A & B TEST
K080380 · PSZ
Sa Scientific, Inc.
Microbiology · 526d
Cleared Jul 22, 2009
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017
K091264 · LTT
Siemens Healthcare Diagnostics
Microbiology · 83d
Cleared Jul 17, 2009
CHROMID MRSA AGAR, MODEL: REF 43 841
K091024 · JSO
bioMerieux, Inc.
Microbiology · 98d
Cleared Jul 09, 2009
XPERT C. DIFFICILE
K091109 · LLH
Cepheid
Microbiology · 84d
Cleared Jul 01, 2009
PLATELIA TOXO IGM KIT MODEL 26211
K090847 · LGD
Bio-Rad Laboratories
Microbiology · 93d
Cleared Jun 25, 2009
E. COLI PNA FISH
K082068 · JSS
Advandx, Inc.
Microbiology · 338d
Cleared Jun 25, 2009
XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112,...
K091667 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 16d
Cleared Jun 18, 2009
VITEK 2 GRAM POSITIVE DAPTOMYCIN
K091126 · LON
bioMerieux, Inc.
Microbiology · 59d
Cleared Jun 08, 2009
SERAQUEST EBV EA-D IGG TEST
K091260 · LSE
Quest Intl., Inc.
Microbiology · 40d
Cleared Jun 05, 2009
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K090971 · LSL
Becton, Dickinson & CO
Microbiology · 60d
Cleared Jun 04, 2009
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
K090968 · NGZ
Trek Diagnostic Systems, Inc.
Microbiology · 59d