Smithkline Diagnostics, Inc. - FDA 510(k) Cleared Devices
42
Total
42
Cleared
0
Denied
42 devices
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
Nov 17, 1977
ASPIRATOR & PROBE, CYTOLOGY, ENDOMET.
Obstetrics & Gynecology
7d
Cleared
Jul 05, 1977
IN VITRO DIAG. FOR URIC ACID
Chemistry
68d
Cleared
Jun 08, 1977
CHOLESTEROL REAGENT
Chemistry
86d
Cleared
Jan 05, 1977
SIGMOIDOSCOPE/ DISPOSABLE
Gastroenterology & Urology
34d
Cleared
Dec 16, 1976
REAL TIME OBSTETRICAL ULTRASONIC SCANNER
Obstetrics & Gynecology
31d
Cleared
Dec 13, 1976
EKOSECTOR I
Obstetrics & Gynecology
31d
Cleared
Sep 13, 1976
TEST, RIA, TRIODOTHYRONINE
Immunology
89d
Cleared
Aug 26, 1976
REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER
Chemistry
71d
Cleared
Jul 16, 1976
TEST, RIA, SERUM DIGOXIN
Toxicology
28d