FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,231 results
11761–11784 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 10, 1980
ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO
K802068 · JJX
Beckman Instruments, Inc.
Chemistry · 44d
Cleared Oct 10, 1980
BAKER DIAG. ULTRARATE CHLORIDE KIT
K802080 · JFS
J.T. Baker Chemical Co.
Chemistry · 43d
Cleared Oct 10, 1980
AMERICAN MONITOR MAGNESIUM #'S 1036&4021
K802091 · JGJ
American Monitor Corp.
Chemistry · 38d
Cleared Oct 10, 1980
KEMTROL SERUM CONTROL-NORMAL
K802108 · JJY
Helena Laboratories
Chemistry · 37d
Cleared Oct 10, 1980
KEMTROL SERUM CONTROL ABNORMAL
K802109 · JJY
Helena Laboratories
Chemistry · 37d
Cleared Oct 10, 1980
TESTOSTERONE RADIOIMMUNOASSY KIT
K802135 · CDZ
Radioimmunoassay, Inc.
Chemistry · 36d
Cleared Oct 10, 1980
DELTA TEST TRIGLYCERIDES
K802136 · CDT
Bd Becton Dickinson Vacutainer...
Chemistry · 36d
Cleared Oct 10, 1980
REAGENTS USED-QUAN. MEASURE OF SERUM
K802154 · CIG
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
REAGENTS SERUM SODIUM USING THE TECH.
K802155 · JGS
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
REAGENTS SERUM CREATINE USING TECHICON
K802156 · CGX
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
BCG REAGENT SERUM ALBUMIN W/TECHNICON
K802157 · CIX
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
POSTASSIUM BUFFER SOL. & WASH SOLUTION
K802158 · CEM
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS
K802159 · CEO
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
BUN COLOR REAGENT & BUN ACID USED
K802160 · CDW
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
BIURET REAGENT & TOTAL PROTEIN BLANK SOL
K802161 · CEK
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
CO2 COLOR REAGENT & CO2 SAMPLE DILUENT
K802162 · KMS
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
CHLORIDE COLOR & CHLORIDE SAMPLE DILUENT
K802163 · CHJ
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM.
K802164 · CIC
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
IN-HOME EARLY PREGNANCY TEST KIT
K802334 · JHJ
Health Diagnostics Corp.
Chemistry · 17d
Cleared Oct 10, 1980
PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO
K802343 · JHJ
Intl. Diagnostic, Inc.
Chemistry · 14d
Cleared Oct 06, 1980
HYCEL TRIGYCERIDE II TEST
K802422
Hycel, Inc.
Chemistry
Cleared Sep 26, 1980
UV URIC ACID STANDARDS
K801501 · JIS
The Dow Chemical Co.
Chemistry · 91d
Cleared Sep 26, 1980
EMBRIA-CK
K801728 · JHX
Intl. Immunoassay Laboratories, Inc.
Chemistry · 64d
Cleared Sep 26, 1980
MODEL 203S CLINICAL CHEMISTRY ANALYZER
K801889 · JJE
Gilford Instrument Laboratories, Inc.
Chemistry · 49d