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
11929–11952 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 14, 1980
NORDICLAB TESTOSTERONE RIA TEST
K800921 · CDZ
Nordiclab Intl.
Chemistry · 23d
Cleared May 14, 1980
NORDICLAB PROGESTERONE RIA TEST
K800922 · JLS
Nordiclab Intl.
Chemistry · 23d
Cleared May 14, 1980
HDL REAGENT
K800996 · LBR
Gilford Diagnostics
Chemistry · 19d
Cleared May 14, 1980
IL SYSTEM 502 NA/K ANALYZER
K801007 · JGS
Instrumentation Laboratory CO
Chemistry · 16d
Cleared May 14, 1980
TRIGLYCERIDE REAGENT (COLOR)
K801012 · JGY
Gilford Diagnostics
Chemistry · 16d
Cleared May 14, 1980
PREZAPAK L ARTERIAL BLOOD SAMPLING KIT
K801015 · GIM
Kimble-Terumo, Inc.
Chemistry · 15d
Cleared May 14, 1980
IMMULON 1, #11-010-3350 & IMMULON 2 #--
K801018
Dynatech Laboratories, Inc.
Chemistry · 14d
Cleared May 08, 1980
ENZYMATIC TRIGLYCERIDES REAFENT FOR SMAC
K800649 · CDT
Reagents Applications, Inc.
Chemistry · 45d
Cleared May 08, 1980
ENZYMATIC UREA NITROGEN REAGENT SET REVI
K800719 · CDQ
Macomb Chemical Co.
Chemistry · 38d
Cleared May 08, 1980
NO-BOIL FOLATE KIT #RP-500
K800914 · CGN
Ria Products, Inc.
Chemistry · 17d
Cleared Apr 29, 1980
FAST HEMOGLOBIN CONTROL-LYOPHILIZED
K800794 · LCP
Isolab, Inc.
Chemistry · 20d
Cleared Apr 29, 1980
FERRO-QUANT TM FE 59 TEST KIT
K800868 · JQG
Mallinckrodt Critical Care
Chemistry · 12d
Cleared Apr 29, 1980
GAL-PUT CONTROLS, NORMAL&DEFICIENT
K800910 · JIX
Sigma Chemical Co.
Chemistry · 8d
Cleared Apr 24, 1980
GAMMA STICK CORTISOL RIA KIT/STICK KIT
K800538 · CGR
Alpha Gamma Laboratory
Chemistry · 45d
Cleared Apr 24, 1980
CENTRIFICHEM CHOLESTEROL
K800765 · CHH
Union Carbide Corp.
Chemistry · 17d
Cleared Apr 24, 1980
Y-GT TEST, Y-GLUTAMYL TRANSFERASE TEST
K800769 · JQB
Sclavo, Inc.
Chemistry · 17d
Cleared Apr 24, 1980
GAS PAK II DIS. GENERATOR ENVELOPES
K800796 · KZJ
Bd Becton Dickinson Vacutainer...
Chemistry · 15d
Cleared Apr 24, 1980
HUMAN THYROID STIM. HORMONE/ARIA II
K800798 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 15d
Cleared Apr 24, 1980
DIAGNOSTIC PRODUCTS CORP. RIA CONTROL
K800813 · JJY
Diagnostic Products Corp.
Chemistry · 13d
Cleared Apr 24, 1980
SERALYZER URIC ACID REAGENT STRIPS -
K800848 · KNK
Miles Laboratories, Inc.
Chemistry · 9d
Cleared Apr 21, 1980
MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEO
K800720
Macomb Chemical Co.
Chemistry · 21d
Cleared Apr 21, 1980
IL MODEL 1303 PH/BLOOD GAS ANALYZER
K800757 · CHL
Instrumentation Laboratory CO
Chemistry · 17d
Cleared Apr 21, 1980
SLAVO CHOLESTEROL STAND. DIAGNOSTIC KIT
K800770 · JIT
Sclavo, Inc.
Chemistry · 14d
Cleared Apr 21, 1980
RENCTK
K800774 · CIB
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 14d