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
2377–2400 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Aug 06, 1998
TOXOGEN
K981263 · GMM
Instrumentation Laboratory CO
Microbiology · 121d
Cleared Aug 05, 1998
STAT-SIMPLE PYLORI
K980782 · LYR
Saliva Diagnostic Systems, Inc.
Microbiology · 156d
Cleared Jul 30, 1998
DIPSTREAK
K974428 · JSI
Novamed , Ltd.
Microbiology · 248d
Cleared Jul 30, 1998
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM
K980821 · LYR
Zeus Scientific, Inc.
Microbiology · 149d
Cleared Jul 30, 1998
PYLORIPROBE
K981396 · LYR
Amdl, Inc.
Microbiology · 104d
Cleared Jul 30, 1998
PASCO MIC AND MIC/ID PANELS
K982235 · JTN
Pasco Laboratories, Inc.
Microbiology · 35d
Cleared Jul 29, 1998
PASCO MIC AND MIC/ID PANELS/ CEFDINIR
K982156 · JWJ
Pasco Laboratories, Inc.
Microbiology · 41d
Cleared Jul 24, 1998
BACT/ALERT 3D MICROBIAL DETECTION SYSTEM
K981736 · MDB
Organon Teknika Corp.
Microbiology · 67d
Cleared Jul 22, 1998
VCA IGM ELISA TEST SYSTEM
K980596 · LSE
Clark Laboratories, Inc.
Microbiology · 155d
Cleared Jul 22, 1998
VCA IGG ELISA TEST SYSTEM
K980912 · LSE
Clark Laboratories, Inc.
Microbiology · 134d
Cleared Jul 17, 1998
COLORPAC TOXIN A
K980185 · LLH
Bd Becton Dickinson Vacutainer...
Microbiology · 178d
Cleared Jul 14, 1998
PAR-ONE
K981391 · LIO
Remel, Inc.
Microbiology · 88d
Cleared Jul 09, 1998
MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA
K982210 · LJC
Dade Behring, Inc.
Microbiology · 16d
Cleared Jul 06, 1998
ADI SYPHILIS RPR LIQUID CONTROLS
K980638 · GMP
Ampcor Diagnostics, Inc.
Microbiology · 137d
Cleared Jul 06, 1998
ETEST CEFDINIR
K980877 · JWY
Ab Biodisk
Microbiology · 119d
Cleared Jun 15, 1998
ETEST BENZYLPENICILLIN
K980335 · JWY
Ab Biodisk
Microbiology · 138d
Cleared Jun 09, 1998
ETEST BENZYLPENICILLIN
K981135 · JWY
Ab Biodisk
Microbiology · 71d
Cleared Jun 09, 1998
ETEST FOSFOMYCIN
K981136 · JWY
Ab Biodisk
Microbiology · 71d
Cleared Jun 09, 1998
ETEST CEFOTAXIME
K981137 · JWY
Ab Biodisk
Microbiology · 71d
Cleared Jun 09, 1998
CEFDINIR, 5 UG, SENSI-DISC
K981517 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 42d
Cleared Jun 05, 1998
ETEST CIPROFLOXACIN
K981138 · JWY
Ab Biodisk
Microbiology · 67d
Cleared Jun 01, 1998
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G)
K971006 · LSR
Mrl Diagnostics
Microbiology · 439d
Cleared Jun 01, 1998
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)
K971007 · LSR
Mrl Diagnostics
Microbiology · 439d
Cleared Jun 01, 1998
ETEST CEFTRIAXONE
K981139 · JWY
Ab Biodisk
Microbiology · 63d