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
6841–6864 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 27, 1990
YSI MODEL 1500 SPORT L-LACTATE ANALYZER
K901131 · KHP
Yellow Springs Instrument Co., Inc.
Chemistry · 168d
Cleared Aug 23, 1990
IL THYROXINE (T4) ASSAY SYSTEM
K903095 · KLI
Instrumentation Laboratory CO
Chemistry · 41d
Cleared Aug 23, 1990
IMX B12
K903218 · LIG
Abbott Laboratories
Chemistry · 31d
Cleared Aug 23, 1990
LIQUICHEK CK/LD ISOENZYME CONTROL
K903430 · JJT
Bio-Rad
Chemistry · 23d
Cleared Aug 22, 1990
STANBIO CSF/URINE TOTAL PROTEIN TEST SET
K902204 · JIR
Stanbio Laboratory
Chemistry · 98d
Cleared Aug 22, 1990
CLP LOW LEVEL HDL CHOLESTEROL -LIPID CONTROL
K902909 · JJY
Creative Laboratory Products, Inc.
Chemistry · 50d
Cleared Aug 22, 1990
KODATROL LIQUID CONTROL LEVELS I & II
K903189 · DIF
Eastman Kodak Company
Chemistry · 34d
Cleared Aug 22, 1990
IL TOBRAMYCIN ASSAY
K903192 · KLB
Instrumentation Laboratory CO
Chemistry · 34d
Cleared Aug 22, 1990
MAGNESIUM
K903341 · JGJ
Catachem, Inc.
Chemistry · 28d
Cleared Aug 22, 1990
MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT
K903359 · CGI
Immunotech Corp.
Chemistry · 28d
Cleared Aug 17, 1990
COBAS READY CALCIUM REAGENT
K896224 · CIC
Roche Diagnostic Systems, Inc.
Chemistry · 291d
Cleared Aug 17, 1990
MONI-TROL XL AND L UNASSAYED LIQUID CHEMISTRY
K903190 · JJY
Medical Analysis Systems, Inc.
Chemistry · 29d
Cleared Aug 17, 1990
ASPARTATE AMINOTRANSFERASE TEST
K903197 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Aug 17, 1990
CHALLENGE BRAND LIQUID MULTI-ENZYME LINEARITY CONT
K903225 · JJY
Medical Analysis Systems, Inc.
Chemistry · 25d
Cleared Aug 17, 1990
SYNERMED CREATININE REAGENT KIT
K903296 · CGX
Synermed, Inc.
Chemistry · 24d
Cleared Aug 17, 1990
SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404
K903332 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Aug 17, 1990
CREATINE KINASE TEST (CK) ITEM NUMBER 65411
K903333 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Aug 17, 1990
SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422
K903335 · CDO
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Aug 09, 1990
VACUTAINER PLUS WITH HEMOGARD CLOSURE
K901449 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 134d
Cleared Aug 09, 1990
CHOLESTEROL (RATE) REAGENT
K902098 · CHH
Sigma Chemical Co.
Chemistry · 93d
Cleared Aug 09, 1990
REFLOTRON HDL CHOLESTEROL TEST TABS
K902568 · LBR
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Aug 09, 1990
PRECINORM HDL CHOLESTEROL CONTROL MATERIAL FOR REF
K902569 · JJX
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Aug 09, 1990
EZ-SCREEN:HCG
K902681 · JHI
Environmental Diagnostics, Inc.
Chemistry · 51d
Cleared Aug 09, 1990
AFFINITY HCG TEST SYSTEM
K902720 · JHI
Bd Becton Dickinson Vacutainer...
Chemistry · 50d