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
12817–12840 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 25, 1977
ACA AMMONIA CALIBRATOR
K771804 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
Cleared Oct 25, 1977
CENTRIFICHEM SYS 400 ANALYZER
K771813 · JJG
Clinical Diagnostics, Inc.
Chemistry · 28d
Cleared Oct 25, 1977
ALBUMIN
K771828 · CIX
Gamma Enterprises, Inc.
Chemistry · 26d
Cleared Oct 25, 1977
BLOOD UREA NITROGEN BUN
K771830 · CDW
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared Oct 25, 1977
CALCIUM
K771831 · CIC
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared Oct 25, 1977
TOTAL PROTEIN
K771841 · CEK
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared Oct 25, 1977
URIC ACID
K771842 · CDH
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared Oct 25, 1977
WASH SOLUTIONS
K771844
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared Oct 21, 1977
17-HYDROXYPROGESTERONE TEST SET
K771729 · JLX
Wien Laboratories, Inc.
Chemistry · 37d
Cleared Oct 19, 1977
CARDIOZYME CK-CONTROL LEVEL 1
K771740 · JJT
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 34d
Cleared Oct 19, 1977
ENZYMATIC CHOLESTEROL
K771820 · CHH
Macomb Chemical Co.
Chemistry · 26d
Cleared Oct 19, 1977
TOTAL BILIRUBIN
K771840 · CIG
Gamma Enterprises, Inc.
Chemistry · 28d
Cleared Oct 19, 1977
PROCEDURE NO. 555
K771916 · CGX
Sigma Chemical Co.
Chemistry · 8d
Cleared Oct 18, 1977
TSH RIA REAGENT SET
K771234 · JLW
G.D. Searle and Co.
Chemistry · 99d
Cleared Oct 18, 1977
ELECTROPHORESIS POWER SUPPLY TESTER
K771322 · JJN
Corning Medical & Scientific
Chemistry · 92d
Cleared Oct 18, 1977
I.L. MODEL 643 FLAME PHOTOMETER
K771337 · JJO
Instrumentation Laboratory CO
Chemistry · 91d
Cleared Oct 18, 1977
NEO TSH-RIA KIT
K771378 · JLW
Nuclear Medical Systems, Inc.
Chemistry · 90d
Cleared Oct 18, 1977
STAT/LYTE ANALYZER
K771592 · JFL
Technicon Instruments Corp.
Chemistry · 60d
Cleared Oct 18, 1977
ALKALINE PHOSPHATASE TEST
K771695 · CJE
Sclavo, Inc.
Chemistry · 42d
Cleared Oct 18, 1977
DERTRAN-COATED CHARCOAL TABLETS
K771704
Reflex Industries, Inc.
Chemistry · 42d
Cleared Oct 18, 1977
TEK-CHEK-2
K771713 · JJW
Miles Laboratories, Inc.
Chemistry · 36d
Cleared Oct 18, 1977
BARBITAL BUFFER
K771721
Sigma Chemical Co.
Chemistry · 35d
Cleared Oct 18, 1977
GLUCOSE REAGENT FOR GLUC. ANALYZER
K771754 · CGA
Harleco
Chemistry · 32d
Cleared Oct 18, 1977
FOLLICLE-STIMULATING HORMONE
K771756 · CGJ
Nichols Institute Diagnostics
Chemistry · 32d