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
1801–1824 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Nov 26, 2003
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN...
K033482 · LON
Dade Behring, Inc.
Microbiology · 22d
Cleared Nov 24, 2003
BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG
K032713 · LSR
Boston Biomedica, Inc.
Microbiology · 83d
Cleared Nov 18, 2003
XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
K031942 · MHI
Remel, Inc.
Microbiology · 147d
Cleared Nov 18, 2003
PASCO MIC AND MIC/ID PANELS
K033119 · JWY
Pasco Laboratories, Inc.
Microbiology · 49d
Cleared Nov 14, 2003
XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
K031965 · MHJ
Remel, Inc.
Microbiology · 141d
Cleared Nov 12, 2003
VITEK 2 GRAM NEGATIVE MOXIFLOXACIN
K032861 · LON
bioMerieux, Inc.
Microbiology · 61d
Cleared Nov 10, 2003
XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
K031834 · MHI
Remel, Inc.
Microbiology · 150d
Cleared Nov 04, 2003
VITEK 2 GRAM NEGATIVE GATIFLOXACIN
K032788 · LON
bioMerieux, Inc.
Microbiology · 57d
Cleared Nov 04, 2003
GIARDIA II
K033274 · MHI
Techlab, Inc.
Microbiology · 25d
Cleared Oct 31, 2003
VITEK GRAM NEGATIVE GATIFLOXACIN
K032711 · LON
bioMerieux, Inc.
Microbiology · 59d
Cleared Oct 31, 2003
VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN
K032738 · LON
bioMerieux, Inc.
Microbiology · 57d
Cleared Oct 31, 2003
VITEK 2 GRAM POSITIVE LINEZOLID
K032766 · LON
bioMerieux, Inc.
Microbiology · 56d
Cleared Oct 31, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS
K032993 · JJX
Ortho-Clinical Diagnostics, Inc.
Microbiology · 36d
Cleared Oct 31, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS
K033127 · JJX
Ortho-Clinical Diagnostics
Microbiology · 31d
Cleared Oct 22, 2003
WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M
K031952 · NOP
Focus Technologies, Inc.
Microbiology · 119d
Cleared Oct 22, 2003
WEST NILE VIRUS ELISA IGG, MODEL EL0300G
K031953 · NOP
Focus Technologies, Inc.
Microbiology · 119d
Cleared Oct 21, 2003
BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY...
K032166 · GQG
Binax, Inc.
Microbiology · 97d
Cleared Oct 06, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/ML
K032655 · LON
Becton, Dickinson & CO
Microbiology · 39d
Cleared Sep 29, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE...
K032275 · LON
Becton, Dickinson & CO
Microbiology · 68d
Cleared Sep 22, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML
K032299 · LON
Becton, Dickinson & CO
Microbiology · 59d
Cleared Sep 17, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE
K032567 · LON
Becton, Dickinson & CO
Microbiology · 28d
Cleared Sep 15, 2003
PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP)
K032518 · JWY
Bd Diagnostic Systems
Microbiology · 32d
Cleared Sep 11, 2003
QUICKVUE INFLUENZA A+B TEST
K031899 · PSZ
Quidel Corp.
Microbiology · 99d
Cleared Sep 11, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML
K032153 · LON
Bd Diagnostic Systems
Microbiology · 59d