Macomb Chemical Co. - FDA 510(k) Cleared Devices
23
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Macomb Chemical Co. Chemistry ✕
20 devices
Cleared
Jan 07, 1983
SPECTROPHOTOMETER
Chemistry
28d
Cleared
May 28, 1980
P-NITROPHENYL PHOSPHATE
Chemistry
21d
Cleared
May 08, 1980
ENZYMATIC UREA NITROGEN REAGENT SET REVI
Chemistry
38d
Cleared
Apr 21, 1980
MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEO
Chemistry
21d
Cleared
Jan 11, 1980
GLUCOSE (HEXOKINASE) REAGENT SET
Chemistry
35d
Cleared
Jan 11, 1980
CREATINE PHOSPHOKINASE (CPK) REAGENT SET
Chemistry
35d
Cleared
Sep 24, 1979
GLUCOSE OXIDASE REAGENT SET
Chemistry
27d
Cleared
Sep 04, 1979
ENZYMATIC REAGENT SET, 4X250 ML.
Chemistry
40d
Cleared
Jul 30, 1979
MACOMB NORMAL CONTROL SERUM
Chemistry
45d
Cleared
Jun 28, 1979
AUTO ENZYMATIC CHOLESTEROL
Chemistry
41d
Cleared
Apr 04, 1979
MACOMB LIPID CONTROL
Chemistry
41d
Cleared
Feb 21, 1979
ALKALINE PHOSPHATASE
Chemistry
37d
Cleared
Aug 10, 1978
LDH (UV KINETIC)
Chemistry
41d
Cleared
Jun 22, 1978
URIC ACID REFERENCE SERA
Chemistry
94d
Cleared
Jun 13, 1978
HDL CHOLESTEROL
Chemistry
54d
Cleared
May 19, 1978
UREA NITROGEN (ENZYMATIC)
Chemistry
46d
Cleared
Jan 30, 1978
SERUM GLUTAMIC OXALOACETIC TRANSAMINASE
Chemistry
27d
Cleared
Oct 19, 1977
ENZYMATIC CHOLESTEROL
Chemistry
26d
Cleared
Sep 02, 1977
TRIGLYCERIDE REAGENT SET
Chemistry
93d
Cleared
Aug 02, 1977
SERUM GLUTAMIC PYRUVIC TRANSAMINASE
Chemistry
62d