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
2161–2184 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 01, 1999
ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K974503 · LSL
Roche Molecular Systems, Inc.
Microbiology · 733d
Cleared Dec 01, 1999
CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC...
K993577 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 41d
Cleared Nov 29, 1999
HYBRID CAPTURE II GC-ID
K981485 · LSL
Digene Corp.
Microbiology · 584d
Cleared Nov 23, 1999
SIRSCAN
K991473 · KZK
Intelligence Artificielle Applications
Microbiology · 210d
Cleared Nov 16, 1999
ETEST FOR QUINUPRISTIN/DALFOPRISTIN
K992993 · LTX
Ab Biodisk
Microbiology · 70d
Cleared Nov 09, 1999
LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY
K991880 · GQN
Light Diagnostics
Microbiology · 160d
Cleared Nov 09, 1999
COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM
K993161 · JTW
Copan Diagnostics, Inc.
Microbiology · 48d
Cleared Nov 04, 1999
BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA...
K984631 · LSL
Becton Dickinson Microbiology Systems
Microbiology · 309d
Cleared Nov 04, 1999
PASCO MIC AND MIC/ID PANELS, CEFDINIR
K992853 · JTN
Pasco Laboratories, Inc.
Microbiology · 72d
Cleared Nov 03, 1999
PASCO MIC AND MIC/ID PANELS, QUINUPRISTIN/DALFOPRISTIN FOR NONFASTIDIOUS...
K992726 · JTN
Pasco Laboratories, Inc.
Microbiology · 82d
Cleared Nov 03, 1999
SYNERCID, 15 UG, BBL SENSI-DISC
K993186 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 42d
Cleared Nov 02, 1999
CDTOX A OIA
K991829 · LLH
Biostar, Inc.
Microbiology · 158d
Cleared Nov 02, 1999
SERAQUEST EB NA IGG
K991975 · LSE
Quest Intl., Inc.
Microbiology · 144d
Cleared Nov 02, 1999
PASCO MIC AND MIC/ID PANELS,QUINUPRISTIN/DALFOPRISTIN
K992717 · JTN
Pasco Laboratories, Inc.
Microbiology · 82d
Cleared Oct 28, 1999
SERAQUEST EB VCA IGG
K990410 · LSE
Quest Intl., Inc.
Microbiology · 261d
Cleared Oct 25, 1999
HYBRID CAPTURE II CT-ID TEST
K990023 · LSK
Digene Corp.
Microbiology · 293d
Cleared Oct 19, 1999
LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295
K990141 · GQW
Light Diagnostics
Microbiology · 273d
Cleared Oct 19, 1999
PASCO MIC AND MIC/ID PANELS, PENICILLIN
K992646 · JTN
Pasco Laboratories, Inc.
Microbiology · 74d
Cleared Oct 19, 1999
PASCO MIC AND MIC/ID PANELS, ERYTHROMYCIN
K992647 · JTN
Pasco Laboratories, Inc.
Microbiology · 74d
Cleared Oct 14, 1999
PASCO MIC AND MIC/ID PANELS, CEFOTAXIME
K992568 · JTN
Pasco Laboratories, Inc.
Microbiology · 73d
Cleared Oct 14, 1999
PASCO MIC AND MIC/ID PANELS, CHLORAMPHENICOL
K992593 · JTN
Pasco Laboratories, Inc.
Microbiology · 72d
Cleared Oct 13, 1999
PASCO MIC AND MIC/ID PANELS, CEFTRIAXONE
K992562 · JTN
Pasco Laboratories, Inc.
Microbiology · 72d
Cleared Oct 12, 1999
PASCO MIC AND MIC/ID PANELS, MEROPENEM
K992546 · JTN
Pasco Laboratories, Inc.
Microbiology · 74d
Cleared Oct 08, 1999
PASCO MIC AND MIC/ID PANELS, TROVAFLOXACIN
K992507 · JTN
Pasco Laboratories, Inc.
Microbiology · 73d