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
2185–2208 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 14, 1999
BACT/ALERT MP PROCESS BOTTLE
K993576 · MDB
Organon Teknika Corp.
Microbiology · 54d
Cleared Dec 10, 1999
PREMIER TOXINS A&B, MODEL 616096
K993914 · LLH
Meridian Diagnostics, Inc.
Microbiology · 23d
Cleared Dec 09, 1999
MICROSTREP PLUS PANEL
K983746 · JWY
Dade Microscan, Inc.
Microbiology · 412d
Cleared Dec 02, 1999
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K993102 · LTT
Dade Microscan, Inc.
Microbiology · 77d
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