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
8137–8160 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 03, 1987
TITAN GEL REP CPK-30 HV
K874139 · CGS
Helena Laboratories
Chemistry · 21d
Cleared Nov 03, 1987
TITAN GEL REP SIMULTANEOUS CK-LD ISOENZYME PROCED.
K874140 · CGS
Helena Laboratories
Chemistry · 21d
Cleared Nov 03, 1987
DYNATECH MR 300 MANUAL MICROELISA
K874244 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 18d
Cleared Oct 29, 1987
QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2
K873011 · LAS
Quantimetrix Medical Industries
Chemistry · 86d
Cleared Oct 29, 1987
EASY-TEST SALICYLATE (SAL) #16691
K873425 · DKJ
Em Diagnostic Systems, Inc.
Chemistry · 65d
Cleared Oct 29, 1987
EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95
K873436 · DLJ
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Oct 29, 1987
AFFINITY TOTAL THYROXINE IMMUNIT
K873518 · KLI
Bd Becton Dickinson Vacutainer...
Chemistry · 58d
Cleared Oct 29, 1987
EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021
K873635 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Oct 29, 1987
EASY-TEST ALBUMIN (ALB), ITEM NO. 19039
K873994 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Oct 29, 1987
MULTICHEM ALBUMIN REAGENT S0902
K874049 · CIX
Simmler, Inc.
Chemistry · 24d
Cleared Oct 28, 1987
SERALYZER III BLOOD CHEMISTRY ANALYZER
K872120 · JJF
Miles Laboratories, Inc.
Chemistry · 149d
Cleared Oct 28, 1987
HCG ENZYME IMMUNOASSAY TEST KIT CATALOG #MB-1013
K873872 · DHA
Medix Biotech, Inc.
Chemistry · 36d
Cleared Oct 28, 1987
MULTICHEM INORGANIC PHOSPHOROUS S0923
K874038 · CEO
Simmler, Inc.
Chemistry · 23d
Cleared Oct 28, 1987
IRON REAGENT
K874055 · JMO
Trace Scientific , Ltd.
Chemistry · 23d
Cleared Oct 23, 1987
DHEA-S RIA KIT
K872879 · JKC
Endocrine Associates, Inc.
Chemistry · 94d
Cleared Oct 23, 1987
SODIUM/POTASSIUM REAGENT KIT
K873126 · JGS
A-Kem, Inc.
Chemistry · 74d
Cleared Oct 23, 1987
CHLORIDE REAGENT KIT
K873127 · JFS
A-Kem, Inc.
Chemistry · 74d
Cleared Oct 23, 1987
GLUCOSE REAGENT KIT
K873128 · CGA
A-Kem, Inc.
Chemistry · 74d
Cleared Oct 23, 1987
CARBON DIOXIDE REAGENT KIT
K873129 · JFL
A-Kem, Inc.
Chemistry · 74d
Cleared Oct 23, 1987
WASH SOLUTION KIT
K873130 · JJE
A-Kem, Inc.
Chemistry · 74d
Cleared Oct 23, 1987
CREATININE REAGENT KIT
K873131 · CGX
A-Kem, Inc.
Chemistry · 74d
Cleared Oct 23, 1987
BUN REAGENT KIT
K873132 · LFP
A-Kem, Inc.
Chemistry · 74d
Cleared Oct 20, 1987
ALBUMIN SCREEN TEST
K870516 · JIQ
Sclavo, Inc.
Chemistry · 258d
Cleared Oct 20, 1987
DIASCAN* BLOOD GLUCOSE SELF-MONITORING TEST STRIPS
K872505 · CGA
Home Diagnostics, Inc.
Chemistry · 118d