Harleco - FDA 510(k) Cleared Devices
116
Total
116
Cleared
0
Denied
105 devices
Cleared
Jul 14, 1977
ULTRAZYME PLUS GOT
Chemistry
59d
Cleared
Jul 14, 1977
AUTO-ENZYMATIC GLUCOSE FOR ANALYZER
Chemistry
59d
Cleared
Jul 14, 1977
AUTO TOTAL PROTEIN FOR ANALYZER
Chemistry
59d
Cleared
Jul 11, 1977
ULTRAZYME PLUS GT
Chemistry
68d
Cleared
Jul 11, 1977
ULTRACHEM ALBUMIN
Chemistry
68d
Cleared
Jul 11, 1977
ULTRACHEM CALCIUM
Chemistry
68d
Cleared
Jul 11, 1977
ULTRAZYME PLUS, LDH
Chemistry
68d
Cleared
Jul 11, 1977
ULTRACHEM CREATININE
Chemistry
68d
Cleared
Jul 11, 1977
ULTRACHEM INORGANIC PHOSPHORUS
Chemistry
68d
Cleared
Jul 11, 1977
UNIPAK HEMOGLOBIN
Chemistry
25d
Cleared
Mar 01, 1977
AUTO-ENZYMATIC GLUCOSE
Chemistry
22d
Cleared
Feb 14, 1977
AUTO CREATININE REAGENT (GILFORD 3400-E)
Chemistry
56d
Cleared
Feb 11, 1977
AUTO CREATININE REAGENT (ABBOTT SYSTEM)
Chemistry
53d
Cleared
Jan 31, 1977
MANUEL BILIRUBIN REAGENT SET
Chemistry
10d
Cleared
Dec 29, 1976
AUTO-INORGANIC PHOSPHORUS REAGENT
Chemistry
16d
Cleared
Dec 29, 1976
AUTO-INORGANIC PHOSPHORUS REAGENT
Chemistry
16d
Cleared
Dec 29, 1976
AUTO-ENZYMATIC GLUCOSE
Chemistry
16d
Cleared
Dec 21, 1976
AUTO TOTAL PROTEIN
Chemistry
14d
Cleared
Dec 21, 1976
AUTO TOTAL BILIRUBIN REAGENT
Chemistry
14d
Cleared
Dec 21, 1976
AUTO TOTAL PROTEIN
Chemistry
14d
Cleared
Nov 30, 1976
AUTO-TOTAL BILIRUBIN REAG FOR GILFORD AN
Chemistry
18d
Cleared
Nov 30, 1976
AUTO-ALBUMIN REAG FOR ABBOTT ABA-100
Chemistry
18d
Cleared
Nov 30, 1976
AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL
Chemistry
18d
Cleared
Sep 21, 1976
ULTRAZYME AMYLASE
Chemistry
99d
Cleared
Sep 15, 1976
CPK - ISOENZYMES
Chemistry
93d
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