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
9025–9048 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 03, 1986
A-GENT LIQUID TOTAL BILIRUBIN
K860424 · CIG
Abbott Laboratories
Chemistry · 58d
Cleared Apr 03, 1986
A-GENT LIQUID CALCIUM
K860425 · CIC
Abbott Laboratories
Chemistry · 58d
Cleared Apr 03, 1986
A-GENT LIQUID TOTAL PROTEIN
K860426 · CEK
Abbott Laboratories
Chemistry · 58d
Cleared Apr 03, 1986
URIC ACID REAGNET SET (TRINDER)
K860477 · KNK
Sterling Diagnostics, Inc.
Chemistry · 55d
Cleared Apr 03, 1986
SGPT (ALT) REAGENT SET (COLORIMETRIC)
K860485 · CKD
Sterling Diagnostics, Inc.
Chemistry · 52d
Cleared Apr 03, 1986
EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93
K860641 · DLI
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Apr 03, 1986
ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET
K860667 · CIT
Sterling Diagnostics, Inc.
Chemistry · 38d
Cleared Apr 03, 1986
ANALYTE IRON/TECHNICON CHEM 1 SYSTEM
K860799 · JIY
Technicon Instruments Corp.
Chemistry · 30d
Cleared Apr 03, 1986
TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN
K860868 · LCD
Technicon Instruments Corp.
Chemistry · 27d
Cleared Apr 03, 1986
EASY-TEST AMLASE (AMYL), #67521/93
K860918 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Apr 03, 1986
PRECINORM IM AND PRECIPATH IM
K860970 · JJY
Boehringer Mannheim Corp.
Chemistry · 22d
Cleared Apr 03, 1986
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/UNASSAYED
K860998 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 16d
Cleared Apr 03, 1986
GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED
K861000 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 16d
Cleared Mar 25, 1986
CEDIA DIGOXIN ASSAY
K854638 · KXT
Microgenics Corp.
Chemistry · 126d
Cleared Mar 17, 1986
ALDOSTERONE DIRECT RIA KIT
K854876 · KQN
Biotecx Laboratories, Inc.
Chemistry · 101d
Cleared Mar 17, 1986
CALIBRATION REFERENCE I & II
K855035 · JJY
Integrated Medical Systems Int'L., Inc.
Chemistry · 90d
Cleared Mar 17, 1986
CHEMISTRY CONTROL N & A
K855036 · JJY
Integrated Medical Systems Int'L., Inc.
Chemistry · 90d
Cleared Mar 17, 1986
LEECO TESTOSTERONE DIAGNOSTIC KIT
K860003 · CDZ
Leeco Diagnostics, Inc.
Chemistry · 74d
Cleared Mar 17, 1986
TSH-IRMA COAT-A-COUNT KIT
K860054 · JLW
Diagnostic Products Corp.
Chemistry · 70d
Cleared Mar 17, 1986
TOTAL BILIRUBIN REAGENT SET
K860214 · CIG
Sterling Diagnostics, Inc.
Chemistry · 54d
Cleared Mar 17, 1986
SUCROSEP LUTEINIZING HORMONE (LH) IRMA
K860308 · CEP
Boots-Celltech Diagnostics, Inc.
Chemistry · 48d
Cleared Mar 17, 1986
GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET
K860348 · JPZ
Sterling Diagnostics, Inc.
Chemistry · 46d
Cleared Mar 17, 1986
BOVINE CHEMISTRY CONTROL I.X AND II.X
K860355 · JJY
American Dade
Chemistry · 46d
Cleared Mar 17, 1986
A-GENT LIQUID ALBUMIN
K860423 · CJW
Abbott Laboratories
Chemistry · 41d