Smithkline Diagnostics, Inc. - FDA 510(k) Cleared Devices
42
Total
42
Cleared
0
Denied
22 devices
Cleared
Mar 01, 1988
(SKD) CHOLESTEROL TEST KIT
Chemistry
77d
Cleared
Mar 05, 1986
SKD ELECTROCHEMICAL SYSTEM (ECS)
Chemistry
103d
Cleared
May 24, 1982
SPIN CHEM REAGENTS & STANDARDS
Chemistry
27d
Cleared
May 14, 1982
TARGET ISOCHECK CONTROL SERUM
Chemistry
17d
Cleared
Sep 14, 1981
SPIN-CHEM TRIGLYCERIDES REAGENT
Chemistry
14d
Cleared
Sep 14, 1981
SPIN-CHEM LD-L REAGENT
Chemistry
14d
Cleared
Jul 23, 1981
ESKAFLOW TEST FOR TRIGLYCERIDES
Chemistry
22d
Cleared
Jul 15, 1981
ESKAFLOW TEST FOR GLUCOSE
Chemistry
14d
Cleared
Feb 26, 1981
ESKACHEM PAP REAGENT
Chemistry
66d
Cleared
Oct 30, 1979
ESKACHEM, CK-MB REAGENT
Chemistry
21d
Cleared
Jul 24, 1979
PLUS CHEM S.C.E. REAGENT
Chemistry
42d
Cleared
Jul 17, 1979
SPIN CHEM REAGENT, DETERMINATION OF LDH-
Chemistry
35d
Cleared
Jul 17, 1979
SPIN CHEM REAGENT, DETERMINATION OF AST
Chemistry
35d
Cleared
Jul 17, 1979
SPIN CHEM, DETERMINATION OF ALT (GPT)
Chemistry
35d
Cleared
Jul 17, 1979
PLUS CHEM, DETERMINATION OF ALT (GPT)
Chemistry
35d
Cleared
Jul 17, 1979
PLUS CHEM, DETERMINATION OF LD (LDH-P)
Chemistry
35d
Cleared
Jun 22, 1979
CK-NUC REAGENT
Chemistry
39d
Cleared
Jun 22, 1979
SPIN CHEM CK-NAC REAGENT
Chemistry
39d
Cleared
Jun 22, 1979
ESKLAB REAGENT TABLETS
Chemistry
39d
Cleared
Jul 05, 1977
IN VITRO DIAG. FOR URIC ACID
Chemistry
68d
Cleared
Jun 08, 1977
CHOLESTEROL REAGENT
Chemistry
86d
Cleared
Aug 26, 1976
REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER
Chemistry
71d