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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
11401–11424 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 10, 1981
TBG DIAGNOSTIC KIT
K811725 · CEF
Immuno Assay Corp.
Chemistry · 22d
Cleared Jul 10, 1981
KING DIAGNOSTICS CHOLESTEROL-FE TEST
K811746 · CHO
King Diagnostics, Inc.
Chemistry · 18d
Cleared Jul 10, 1981
KING DIAGNOSTICS CHOLESTEROL TEST
K811747 · CGO
King Diagnostics, Inc.
Chemistry · 18d
Cleared Jul 10, 1981
KING DIAGNOSTICS CALCIUM TEST
K811748 · CIC
King Diagnostics, Inc.
Chemistry · 18d
Cleared Jul 10, 1981
KING DIAGNOSTICS PHOSPHORUS TEST
K811749 · CEO
King Diagnostics, Inc.
Chemistry · 18d
Cleared Jul 10, 1981
CHOLESTEROL DETERMINATION
K811760 · CHH
Biorent Diagnostic, Inc.
Chemistry · 18d
Cleared Jul 10, 1981
QUANTAPHASE T-4 RIA
K811787 · CDX
Bio-Rad
Chemistry · 17d
Cleared Jul 10, 1981
FERRITIN RIA KIT
K811804 · DBF
Amersham Corp.
Chemistry · 16d
Cleared Jul 10, 1981
AUTOPAK-12 FERRITIN KIT
K811808 · DBF
Micromedic Systems
Chemistry · 15d
Cleared Jul 10, 1981
ANTI-ARRHYTHMIC CONTROL LEVELS I & II
K811809 · DIF
Environmental Chemical Specialties
Chemistry · 15d
Cleared Jul 10, 1981
TDM ANTI-CONVULSANT CONTROL LEVELS I-II
K811811 · DIF
Environmental Chemical Specialties
Chemistry · 15d
Cleared Jul 10, 1981
COAT-A-COUNT GENTAMICIN RIA KIT
K811844 · DJB
Diagnostic Products Corp.
Chemistry · 9d
Cleared Jul 10, 1981
FLUOROMATIC THEOPHYLLINE FIA
K811856 · LER
Bio-Rad
Chemistry · 9d
Cleared Jul 10, 1981
SELECT-A-FLOW
K811857 · KNK
Wenmar Intl. Corp.
Chemistry · 9d
Cleared Jul 01, 1981
LIQUIZYME SINGLE SOLUTION GLUCOSE REAG
K811592 · CGA
Amresco, Inc.
Chemistry · 23d
Cleared Jul 01, 1981
URIC ACID TEST
K811687 · KNK
King Diagnostics, Inc.
Chemistry · 16d
Cleared Jul 01, 1981
CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT
K811694 · CKA
Baker Instructions Corp.
Chemistry · 16d
Cleared Jul 01, 1981
HELENA FETAL-TEK 200 MARKER
K811695 · JJY
Helena Laboratories
Chemistry · 15d
Cleared Jul 01, 1981
IL #781, SEMI-AUTOMATED LOADER
K811696 · JQW
Instrumentation Laboratory CO
Chemistry · 15d
Cleared Jul 01, 1981
CHLORIDE/CARBON DIOXIDE RATE REAGENT
K811701 · JFS
Chem-Elec, Inc.
Chemistry · 15d
Cleared Jun 26, 1981
CREATININE REAGENT
K811659 · CGX
Gilford Diagnostics
Chemistry · 14d
Cleared Jun 25, 1981
ACTH RADIOIMMUNOASSAY KIT
K811565 · CKG
Immuno Nuclear Corp.
Chemistry · 21d
Cleared Jun 25, 1981
C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT
K811566 · CEW
Immuno Nuclear Corp.
Chemistry · 21d
Cleared Jun 25, 1981
CARDIOZYME PLUS CK-MB ITEM #65045
K811573 · JHW
Harleco
Chemistry · 21d