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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,249 results
11785–11808 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Sep 26, 1980
MICROLAB M-MICROPROCESSOR DILUTER/DISP
K801913 · JQW
Hamilton Co.
Chemistry · 46d
Cleared Sep 26, 1980
MICRO-FLOW SPECTROPHOTOMETER CL-720
K801957 · JJQ
Shimadzu Precision Instruments, Inc.
Chemistry · 39d
Cleared Sep 26, 1980
NORDICLAB PROSTATIC ACID PHOSPHATASE RIA
K801988 · JFH
Nordiclab Intl.
Chemistry · 38d
Cleared Sep 26, 1980
BAKER DIAG. ULTRARATE CO2 REAGENT KIT
K802035 · JFL
J.T. Baker Chemical Co.
Chemistry · 35d
Cleared Sep 26, 1980
DATA-ZYME UREA NITROGEN REAGENT SET
K802061 · CDQ
Data Medical Associates, Inc.
Chemistry · 32d
Cleared Sep 26, 1980
DUPONT ACALACTIC ACID (LA) TEST
K802064 · KHP
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 30d