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
8401–8424 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 26, 1987
CIBA CORNING MAGIC LITE ANALYZER II
K871874 · JJQ
Ciba Corning Diagnostics Corp.
Chemistry · 12d
Cleared May 20, 1987
ABBOTT TESTPACK HCG COMBO
K870739 · JHI
Abbott Laboratories
Chemistry · 83d
Cleared May 20, 1987
SYNTRON BIORESEARCH EZ CHECK HCG PREGNANCY TEST
K870751 · JHI
Syntron Bioresearch, Inc.
Chemistry · 84d
Cleared May 20, 1987
FOLLICLE STIMULATING HORMONE (HFSH)
K871317 · CGJ
Immuchem Corp.
Chemistry · 48d
Cleared May 20, 1987
TYTEM(R) REAGENT DISPENSER
K871687 · JQW
Medical Laboratory Automation...
Chemistry · 21d
Cleared May 18, 1987
REAGENTS 1263,1273,1284,1425,014301,053583
K871531 · CIG
American Research Products Co.
Chemistry · 28d
Cleared May 18, 1987
ENZYMATIC CHOLESTEROL REAGENT SET
K871676 · CHH
Michclone Associates, Inc.
Chemistry · 20d
Cleared May 14, 1987
CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY
K870965 · CDX
Ciba Corning Diagnostics Corp.
Chemistry · 65d
Cleared May 14, 1987
VISION (TM) HDL CHOLESTEROL
K871461 · LBS
Abbott Laboratories
Chemistry · 30d
Cleared May 14, 1987
TOTAL BILIRUBIN REAGENT 1372,1425,1284,1273,053583
K871530 · CIG
American Research Products Co.
Chemistry · 24d
Cleared May 14, 1987
HPROLACTIN KIT
K871542 · CFT
Immuchem Corp.
Chemistry · 24d
Cleared May 13, 1987
ABBOTT A-GENT LD-1 ISOZYME REAGENT
K871240 · JGF
Abbott Laboratories
Chemistry · 47d
Cleared May 12, 1987
KODAK EKTACHEM DT SLIDES (CA)
K870035 · CID
Eastman Kodak Company
Chemistry · 127d
Cleared May 12, 1987
IONOMETER EF AND ACCESSORIES
K870183 · JGS
Smash Ent., Inc.
Chemistry · 116d
Cleared May 12, 1987
AVL MODEL 985 ELECTROLYTE ANALYZER
K870657 · CEM
Avl Scientific Corp.
Chemistry · 83d
Cleared May 12, 1987
ACU-PREG-AL SLIDE TEST
K871294 · JHJ
Papibris Scientific, Inc.
Chemistry · 42d
Cleared May 12, 1987
EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95
K871638 · JIX
Em Diagnostic Systems, Inc.
Chemistry · 15d
Cleared May 12, 1987
DELFIA (TM) HTSH KIT
K871644 · JLW
Lkb Instruments, Inc.
Chemistry · 15d
Cleared May 12, 1987
GLUCOSE ENZYME - COLOR REAGENT SET
K871650 · CGA
Biochemical Trade, Inc.
Chemistry · 14d
Cleared May 12, 1987
COLORIMETRIC BUN REAGENT KIT
K871651 · CDL
Biochemical Trade, Inc.
Chemistry · 14d
Cleared May 12, 1987
CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS
K871677 · JHY
Catachem, Inc.
Chemistry · 14d
Cleared May 08, 1987
(FPIA) ASSAY BUFFER
K871486 · JJF
Windsor Laboratories, Inc.
Chemistry · 23d
Cleared May 08, 1987
RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL
K871508 · CDT
Trace Scientific , Ltd.
Chemistry · 22d
Cleared May 08, 1987
RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL)
K871509 · CDT
Trace Scientific , Ltd.
Chemistry · 22d