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
1681–1704 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared Nov 19, 2004
WEST NILE DETECT IGM ELISA
K041817 · NOP
Inbios Intl., Inc.
Microbiology · 136d
Cleared Nov 19, 2004
ETEST FOR GEMIFLOXACIN
K042390 · JWY
Ab Biodisk
Microbiology · 78d
Cleared Nov 15, 2004
XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B
K041951 · LLH
Remel, Inc.
Microbiology · 118d
Cleared Oct 22, 2004
IDI-MRSA ASSAY
K042357 · NQX
Infectio Diagnostic (I.D.I.), Inc.
Microbiology · 52d