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
9385–9408 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 10, 1985
CHLORIDE
K850935 · CHJ
Dilab, Inc.
Chemistry · 95d
Cleared Jun 10, 1985
UREA
K850937 · CDW
Dilab, Inc.
Chemistry · 95d
Cleared Jun 10, 1985
CLINICAL CHEMISTRY ANALYTICAL SYSTEM
K851933 · JJF
Allied Instrumentation Laboratory
Chemistry · 39d
Cleared Jun 10, 1985
G-GT REAGENT
K851999 · JQB
Alpkem Corp.
Chemistry · 34d
Cleared Jun 10, 1985
AMY REAGENT
K852001 · JFJ
Alpkem Corp.
Chemistry · 34d
Cleared Jun 10, 1985
TP BIURET REAGENT
K852006 · CEK
Alpkem Corp.
Chemistry · 34d
Cleared Jun 10, 1985
GLUCOSE(TRINDER) REAGENT
K852130 · CGA
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Jun 10, 1985
BUN(ENDPOINT) REAGENT
K852131 · CDQ
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Jun 06, 1985
SOMATOMEDIN C BY RADIOIMMUNOASSAY
K850892 · CFL
Immuno Nuclear Corp.
Chemistry · 94d
Cleared Jun 06, 1985
ESTRADIOL DIRECT RIA KIT
K851540 · CHP
Biotecx Laboratories, Inc.
Chemistry · 51d
Cleared Jun 03, 1985
AST ASPARTATE AMINOTRANSFERASE REAGENT
K851994 · CIT
Alpkem Corp.
Chemistry · 27d
Cleared May 31, 1985
DELFIA HTSH KIT
K851120 · JLW
Lkb Instruments, Inc.
Chemistry · 73d
Cleared May 31, 1985
COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY
K851942 · JJY
Coulter Electronics, Inc.
Chemistry · 28d
Cleared May 31, 1985
ENDAB TSH
K851980 · JLW
Immunotech Corp.
Chemistry · 24d
Cleared May 31, 1985
LD-L REAGENT
K851996 · CFJ
Alpkem Corp.
Chemistry · 24d
Cleared May 31, 1985
IP ACID REAGENT IP MOLY BDATE REAGENT
K852003 · CEO
Alpkem Corp.
Chemistry · 24d
Cleared May 31, 1985
SC-360 SPECTROPHOTOMETER
K852047 · JJQ
Pharmacia, Inc.
Chemistry · 22d
Cleared May 31, 1985
DIRECT BILIRUBEN CALIBRATIONS
K852067 · JIT
Data Medical Associates, Inc.
Chemistry · 21d
Cleared May 31, 1985
TOTAL BILIRUBIN STANDARDS
K852068 · JIS
Data Medical Associates, Inc.
Chemistry · 21d
Cleared May 31, 1985
INORGANIC PHOSPHORUS LIQUID STABLE REAGENT INORGAN
K852103 · CEO
Medical Analysis Systems, Inc.
Chemistry · 16d
Cleared May 30, 1985
CRE BUFFER CRE DYE
K851993 · CGX
Alpkem Corp.
Chemistry · 23d
Cleared May 30, 1985
ALT (ALANINE AMINO-THRANSFERASE)REAGENT
K851995 · CKA
Alpkem Corp.
Chemistry · 23d
Cleared May 30, 1985
LD-P REAGENT
K851997 · CFJ
Alpkem Corp.
Chemistry · 23d
Cleared May 30, 1985
ALP(ALKALINE)(PHOSPHATASE) REAGENT
K851998 · CJE
Alpkem Corp.
Chemistry · 23d