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
9577–9600 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 18, 1985
GLUCOSE(HEXOKINASE) REAGENT SET
K844998 · CFR
Sterling Biochemical, Inc.
Chemistry · 23d
Cleared Jan 18, 1985
BAKER CKMB REAGENT SET
K845024 · JHY
Hybritech, Inc.
Chemistry · 22d
Cleared Jan 18, 1985
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K845027 · CHI
Eastman Kodak Company
Chemistry · 22d
Cleared Jan 16, 1985
BP 5000
K843137 · DXN
Tech Vend Marketing
Chemistry · 160d
Cleared Jan 08, 1985
UROCYSTIN
K843382 · JLC
Mission Pharmacal Co.
Chemistry · 133d
Cleared Jan 08, 1985
LYPHOCHEK PREGNANCY CONTROL SERUM HUMAN
K844125 · JJY
Bio-Rad
Chemistry · 77d
Cleared Jan 08, 1985
ALT/GPT REAGENT SET
K844251 · CKA
Sterling Biochemical, Inc.
Chemistry · 67d
Cleared Jan 08, 1985
DATA-CHEM MAGNESIUM
K844278 · JGJ
Data Medical Associates, Inc.
Chemistry · 64d
Cleared Jan 08, 1985
CRITIC-ARS
K844709 · JIX
Dimension Diagnostics
Chemistry · 36d
Cleared Jan 08, 1985
FOCUS UREA NITROGEN
K844755 · CDQ
Abbott Laboratories
Chemistry · 33d
Cleared Jan 08, 1985
UROL-QUAL
K844760 · JJY
Dimension Diagnostics
Chemistry · 32d
Cleared Jan 08, 1985
MODIFY ELECTROLYTE ANALYZER MODEL SERA-210
K844806 · CEM
Horiba Instruments, Inc.
Chemistry · 28d
Cleared Jan 07, 1985
PERIDOCHROM CHOLESTEROL HIGH PERFORMANCE
K844655 · CHH
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Jan 07, 1985
EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD
K844710 · JJN
Logos Scientific, Inc.
Chemistry · 35d
Cleared Jan 07, 1985
EPPENDORF DILUTER
K844798 · JQW
Medical Technomics, Ltd.
Chemistry · 27d
Cleared Jan 04, 1985
LEUKOSTIX REAGENT STRIPS FOR URINALYSIS
K843727 · LJX
Miles Laboratories, Inc.
Chemistry · 102d
Cleared Jan 03, 1985
AUTOLOADER II
K843779 · JQW
Electro-Nucleonics Laboratories, Inc.
Chemistry · 100d
Cleared Jan 03, 1985
STAT/PB REAGENT
K843839 · DOF
Tri-Tech, Inc.
Chemistry · 94d
Cleared Jan 03, 1985
CALCIUM REAGENT FOR DEMAND ANALYZER
K844241 · CIC
Advanced Biomedical Methods, Inc.
Chemistry · 63d
Cleared Jan 03, 1985
CHOLESTEROL REAGENT FOR DEMAND ANALYZER
K844242 · CHH
Advanced Biomedical Methods, Inc.
Chemistry · 63d
Cleared Jan 03, 1985
TOTAL BILIRUBIN FOR DEMAND ANALYZER
K844243 · CIC
Advanced Biomedical Methods, Inc.
Chemistry · 63d
Cleared Jan 03, 1985
RAICHEM PHOSPHORUS REAGENT
K844316 · CEO
Reagents Applications, Inc.
Chemistry · 48d
Cleared Jan 03, 1985
ALBUMIN REAGENT FOR DEMAND ANALYZER
K844330 · CIX
Advanced Biomedical Methods, Inc.
Chemistry · 57d
Cleared Jan 03, 1985
TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER
K844331 · CEK
Advanced Biomedical Methods, Inc.
Chemistry · 57d