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: Chemistry ×
13,237 results
3745–3768 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 14, 1999
HICHEM BUN REAGENT
K992847 · LFP
Elan Holdings, Inc.
Chemistry · 51d
Cleared Oct 08, 1999
HDL-C/LDL-C CALIBRATOR, MODEL 1913-003
K993098 · JIX
Data Medical Associates, Inc.
Chemistry · 22d
Cleared Oct 08, 1999
ACON COMBO PREGNANCY
K993065 · JHI
ACON Laboratories, Inc.
Chemistry · 25d
Cleared Oct 08, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK
K992366 · MMI
Ortho-Clinical Diagnostics, Inc.
Chemistry · 85d
Cleared Oct 06, 1999
MODIFICATION TO IMX HOMOCYSTEINE
K992274 · LPS
Axis Biochemicals, Asa
Chemistry · 92d
Cleared Oct 05, 1999
ALCYON 300I (WITH ISE MODULE) ANALYZER
K993083 · CEM
Abbott Laboratories
Chemistry · 20d
Cleared Oct 04, 1999
GENZYME DIRECT AMYLASE VERIFIER
K993132 · JIT
Genzyme Corp.
Chemistry · 14d
Cleared Oct 04, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK
K993068 · JHX
Ortho-Clinical Diagnostics
Chemistry · 21d
Cleared Oct 04, 1999
CARDIOQUANT TROPONIN I TEST
K992127 · MMI
Spectral Diagnostics, Inc.
Chemistry · 103d
Cleared Sep 30, 1999
INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC
K990992 · LCP
Roche Diagnostics Corp.
Chemistry · 190d
Cleared Sep 28, 1999
SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS...
K992801 · CIT
Sigma Diagnostics, Inc.
Chemistry · 40d
Cleared Sep 28, 1999
SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P,...
K992800 · CDQ
Sigma Diagnostics, Inc.
Chemistry · 40d
Cleared Sep 28, 1999
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P,...
K992798 · CDO
Sigma Diagnostics, Inc.
Chemistry · 40d
Cleared Sep 28, 1999
ELECSYS PARATHYROID HORMONE TEST SYSTEM
K992680 · CEW
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Sep 24, 1999
PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM
K992988 · CGA
Home Diagnostics, Inc.
Chemistry · 21d
Cleared Sep 24, 1999
ELECSYS ESTRADIOL CALSET II
K992981 · JIT
Roche Diagnostics Corp.
Chemistry · 21d
Cleared Sep 24, 1999
HEMOCHEK URINE COLLECTION KIT
K991800 · JIQ
Osborn Group, Inc.
Chemistry · 121d
Cleared Sep 23, 1999
VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE
K991551 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 143d
Cleared Sep 17, 1999
GAMMA-B 25-HYDROXY VITAMIN D RIA
K991998 · MRG
Immunodiagnostic Systems , Ltd.
Chemistry · 95d
Cleared Sep 17, 1999
MEDI-TEST COMBI 11
K991927 · JIL
Macherey-Nagel-Duren
Chemistry · 101d
Cleared Sep 17, 1999
DRX QT. HCG
K991532 · DHA
Metrika, Inc.
Chemistry · 137d
Cleared Sep 17, 1999
EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP
K991480 · CGA
Selfcare, Inc.
Chemistry · 142d
Cleared Sep 15, 1999
CARESIDE CO2, TOTAL
K992475 · KHS
Careside, Inc.
Chemistry · 51d
Cleared Sep 15, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
K992399 · CIX
Bayer Corp.
Chemistry · 58d