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
12361–12384 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 01, 1979
DATA-ZYME CK CALORIMETRIC/UV PROCEDURE
K790343 · JHS
Data Medical Associates, Inc.
Chemistry · 69d
Cleared May 01, 1979
COULTER ACCU-ZYME II GPT REAGENT
K790522 · CKA
Coulter Electronics, Inc.
Chemistry · 53d
Cleared Apr 26, 1979
TY RIA KIT, AUTOMATED ASSAY SYSTEM
K790477 · CDX
E. R. Squibb & Sons, Inc.
Chemistry · 48d
Cleared Apr 23, 1979
FLOZYME* URIC ACID REAGENT
K790486 · KNK
Worthington Diagnostic Systems
Chemistry · 42d
Cleared Apr 20, 1979
T3 UPTAKE KIT
K790417 · KHQ
E. R. Squibb & Sons, Inc.
Chemistry · 51d
Cleared Apr 20, 1979
MULTISKAN (78-503-00)
K790422 · JJQ
Flow Laboratories, Inc.
Chemistry · 51d
Cleared Apr 17, 1979
P.A.P. TEST KIT, RIA-ZYME
K790040 · JFH
Mallinckrodt Critical Care
Chemistry · 99d
Cleared Apr 04, 1979
PREGNANCY, SENSIDEX TUBE TEST
K782063 · JHJ
Ortho Diagnostics, Inc.
Chemistry · 114d
Cleared Apr 04, 1979
SLIDE TEST FOR PREGNANCY, GRAVINDEX 90
K782166 · JHJ
Ortho Diagnostics, Inc.
Chemistry · 96d
Cleared Apr 04, 1979
NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD)
K790248 · CFJ
Boehringer Laboratories
Chemistry · 55d
Cleared Apr 04, 1979
ANALYZER, CENTRIFUCHEM SYSTEM 400
K790278 · JJG
Union Carbide Corp.
Chemistry · 54d
Cleared Apr 04, 1979
UNION CARBIDE CORP. COMPUTER INTERFACE
K790336 · JQP
Union Carbide Corp.
Chemistry · 42d
Cleared Apr 04, 1979
CPK-CS
K790357 · JHT
Hoffmann-La Roche, Inc.
Chemistry · 40d
Cleared Apr 04, 1979
MACOMB LIPID CONTROL
K790371 · JJY
Macomb Chemical Co.
Chemistry · 41d
Cleared Apr 04, 1979
DUPONT ACA CKMB VERIFIERS
K790376 · JJX
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 40d
Cleared Apr 04, 1979
STREP BLOOD AGAR-5% SHEEP BLOOD
K790469 · JSI
Biomedia, Inc.
Chemistry · 30d
Cleared Apr 03, 1979
A-GENT IMMUNOGLOBULINE TEST SYSTEM
K790479 · CZP
Abbott Laboratories
Chemistry · 26d
Cleared Mar 21, 1979
RIA SYSTEM, PARATHYROID HORMONE
K782081 · CEW
Iso-Tex Diagnostics
Chemistry · 98d
Cleared Mar 21, 1979
SERUM PAK, HCG CONTROL
K790129 · JJX
Mallinckrodt Critical Care
Chemistry · 57d
Cleared Mar 21, 1979
DATA-TOPE TRI-RAC RADIOASSAY CONTROL
K790264 · JJY
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 43d
Cleared Mar 21, 1979
SENSI-TEX
K790267 · JHJ
Hoffmann-La Roche, Inc.
Chemistry · 43d
Cleared Mar 21, 1979
DIAGNOSTIC SET, LIPO-FRAX
K790281 · LBS
Analytical Products, Inc.
Chemistry · 36d
Cleared Mar 21, 1979
BUFFER, CORNING MOPSO
K790294 · JHX
Corning Medical & Scientific
Chemistry · 41d
Cleared Mar 15, 1979
DEHYDROGENOSE, GLUCOSE PHOSPHATE
K790211 · JBL
Sigma Chemical Co.
Chemistry · 43d