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
1705–1728 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 18, 2005
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE
K050585 · LRG
Dade Behring, Inc.
Microbiology · 11d
Cleared Mar 16, 2005
IMMUNOCARD STAT! FLU A & B
K041626 · PSZ
Meridian Bioscience, Inc.
Microbiology · 273d
Cleared Mar 15, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 UG/ML
K043458 · LON
Becton, Dickinson & CO
Microbiology · 90d
Cleared Mar 14, 2005
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE
K043144 · LSL
Gen-Probe, Inc.
Microbiology · 119d
Cleared Feb 28, 2005
VITEK 2 GRAM POSITIVE DAPTOMYCIN
K050075 · LON
bioMerieux, Inc.
Microbiology · 47d
Cleared Feb 28, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN-SULBACTAM (GP) 2-32 UG/ML
K050089 · LON
Becton, Dickinson & CO
Microbiology · 45d
Cleared Feb 18, 2005
VITEK 2 GRAM POSITIVE ERTAPENEM
K050076 · LON
bioMerieux, Inc.
Microbiology · 37d
Cleared Feb 17, 2005
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16...
K043545 · LRG
Dade Behring, Inc.
Microbiology · 56d
Cleared Feb 17, 2005
VITEK 2 COMPACT
K050002 · LON
bioMerieux, Inc.
Microbiology · 45d
Cleared Feb 14, 2005
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM
K043589 · JWY
Dade Microscan, Inc.
Microbiology · 48d
Cleared Feb 10, 2005
GEMIFLOXACIN, 5UG BBL SENSI-DISC
K050062 · JTN
Becton, Dickinson & CO
Microbiology · 30d
Cleared Jan 27, 2005
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS
K043072 · MKZ
Gen-Probe, Inc.
Microbiology · 80d
Cleared Jan 21, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN)...
K043389 · LON
Becton, Dickinson & CO
Microbiology · 43d
Cleared Jan 07, 2005
B-R-A-H-M-S PCT LIA
K040887 · NTM
Brahms Aktiengesellschaft
Microbiology · 277d
Cleared Dec 30, 2004
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM
K043230 · LON
bioMerieux, Inc.
Microbiology · 38d
Cleared Dec 23, 2004
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN
K043237 · LON
bioMerieux, Inc.
Microbiology · 31d
Cleared Dec 13, 2004
HELICOBACTER PYLORI IGG ELISA
K041238 · LYR
Biohit Plc
Microbiology · 216d
Cleared Dec 13, 2004
DAPTOMYCIN
K042392 · JWY
Ab Biodisk
Microbiology · 102d
Cleared Dec 13, 2004
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM
K042963 · LON
bioMerieux, Inc.
Microbiology · 47d
Cleared Dec 07, 2004
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN
K042946 · LON
bioMerieux, Inc.
Microbiology · 42d
Cleared Dec 07, 2004
COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM
K042970 · JSM
Copan Diagnostics, Inc.
Microbiology · 40d
Cleared Dec 02, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4...
K042932 · LON
Becton, Dickinson & CO
Microbiology · 41d
Cleared Nov 22, 2004
STATUS FIRST STREP A
K040708 · GTY
Princeton BioMeditech Corp.
Microbiology · 249d
Cleared Nov 22, 2004
BBLCHROMAGAR MRSA
K042812 · JSO
Becton, Dickinson & CO
Microbiology · 41d