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
8233–8256 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 02, 1987
BIOTROL REFERENCE
K873118 · JIX
Biotrol, USA, Inc.
Chemistry · 23d
Cleared Sep 02, 1987
BIOTROL MAGNESIUM CALMAGITE
K873180 · JGJ
Biotrol, USA, Inc.
Chemistry · 21d
Cleared Sep 02, 1987
ABBOTT SPECTRUM(R) LIQUID CREATININE REAGENT
K873310 · CGX
Abbott Laboratories
Chemistry · 15d
Cleared Aug 31, 1987
BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT
K873117 · CGA
Biotrol, USA, Inc.
Chemistry · 21d
Cleared Aug 28, 1987
ANTEK 703C CHEMILUMINESCENT NITROGEN ANALYZER
K864849 · JJE
Antek Instruments, Inc.
Chemistry · 261d
Cleared Aug 28, 1987
CURAD MEDICATED PLASTIC STRIPS
K872310 · CGX
The Kendal Co.
Chemistry · 74d
Cleared Aug 28, 1987
EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93
K872321 · DKJ
Em Diagnostic Systems, Inc.
Chemistry · 72d
Cleared Aug 28, 1987
CEDIA DIGOXIN CR ASSAY
K872583 · KXT
Microgenics Corp.
Chemistry · 59d
Cleared Aug 28, 1987
TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
K873049 · CDT
Boehringer Mannheim Corp.
Chemistry · 24d
Cleared Aug 26, 1987
ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST
K871601 · LCX
Advanced Care Products
Chemistry · 124d
Cleared Aug 26, 1987
BILE ACIDS REAGENT
K872296 · KWW
Sigma Diagnostics, Inc.
Chemistry · 71d
Cleared Aug 26, 1987
BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL
K872777 · JJY
Biotrol, USA, Inc.
Chemistry · 43d
Cleared Aug 26, 1987
BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM
K872785 · JJY
Biotrol, USA, Inc.
Chemistry · 43d
Cleared Aug 25, 1987
TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY
K872131 · CEP
Hybritech, Inc.
Chemistry · 82d
Cleared Aug 25, 1987
CIBA CORNING 288 PH/BLOOD GAS SYSTEM
K872888 · JQY
Ciba Corning Diagnostics Corp.
Chemistry · 33d
Cleared Aug 25, 1987
ABBOTT A-GENT IRON REAGENT KIT
K873120 · CFM
Abbott Laboratories
Chemistry · 15d
Cleared Aug 21, 1987
CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD
K870362 · CIC
Trace Scientific , Ltd.
Chemistry · 205d
Cleared Aug 21, 1987
CHLORIDE REAGENT - THIOCYANATE METHOD
K870367 · CHJ
Trace Scientific , Ltd.
Chemistry · 205d
Cleared Aug 21, 1987
GEN-PROBE (R) LUMINOMETER - LEADER (TM)
K872219 · JJQ
Gen-Probe, Inc.
Chemistry · 70d
Cleared Aug 21, 1987
CEDIA(TM) T UPTAKE
K872447 · KHQ
Microgenics Corp.
Chemistry · 59d
Cleared Aug 21, 1987
BILE ACIDS CALIBRATOR
K872451 · JIT
Sigma Diagnostics, Inc.
Chemistry · 59d
Cleared Aug 21, 1987
VISION(R) TOTAL BILIRUBIN
K872487 · CIG
Abbott Laboratories
Chemistry · 59d
Cleared Aug 21, 1987
EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95
K872512 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Aug 21, 1987
EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604
K872513 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 58d