Omega Medical Electronics - FDA 510(k) Cleared Devices
21
Total
21
Cleared
0
Denied
FDA 510(k) Regulatory Record - Omega Medical Electronics Chemistry ✕
20 devices
Cleared
Jan 07, 1983
PHOSPHORUS REAGENT SET
Chemistry
30d
Cleared
Jul 22, 1982
GLUCOSE(ENZYMATIC) REAGENT SET
Chemistry
86d
Cleared
Jul 22, 1982
SGPT-UV REAGENT SET
Chemistry
86d
Cleared
Jul 22, 1982
UREA NITROGEN REAGENT SET
Chemistry
86d
Cleared
Jul 20, 1982
LDH-UV REAGENT SET
Chemistry
84d
Cleared
Jul 20, 1982
TRIGLYCERIDE REAGENT SET
Chemistry
84d
Cleared
Jul 20, 1982
SGOT-UV REAGENT SET
Chemistry
84d
Cleared
Jul 14, 1982
SGPT REAGENT SET
Chemistry
78d
Cleared
Jul 14, 1982
SGOT REAGENT SET
Chemistry
78d
Cleared
Jul 13, 1982
ALBUMIN REAGENT SET
Chemistry
77d
Cleared
Jul 13, 1982
CHOLESTEROL REAGENT SET
Chemistry
77d
Cleared
Jul 13, 1982
SERUM CALCIUM REAGENT SET
Chemistry
77d
Cleared
Jul 13, 1982
TOTAL BILIRUBIN REAGENT SET
Chemistry
77d
Cleared
Jul 13, 1982
DIRECT GLUCOSE REAGENT SET
Chemistry
77d
Cleared
Jul 13, 1982
CREATININE REAGENT SET
Chemistry
77d
Cleared
Jul 13, 1982
ALKALINE PHOSPHOTASE REAGENT SET
Chemistry
77d
Cleared
Jul 13, 1982
HDL PRECIPITANT REAGENT SET
Chemistry
77d
Cleared
Jul 13, 1982
SERUM TOTAL PROTEIN REAGENT SET
Chemistry
77d
Cleared
Jul 13, 1982
URIC ACID REAGENT SET
Chemistry
77d
Cleared
May 21, 1982
URIC ACID REAGENT SET(ENZYMATIC
Chemistry
24d