Sclavo, Inc. - FDA 510(k) Cleared Devices
82
Total
82
Cleared
0
Denied
61 devices
Cleared
Jun 19, 1986
IMMPULSE FERRITIN ASSAY REAGENT
Chemistry
22d
Cleared
Apr 28, 1986
IMMPULSE FREE ESTRIOL ASSAY REAGENTS
Chemistry
49d
Cleared
Apr 07, 1986
ALPHA-AMYLASE TEST
Chemistry
42d
Cleared
Jan 22, 1986
TRIGLYCERIDE'S TEST (TRIGLI-CINET)
Chemistry
54d
Cleared
Mar 29, 1985
ISOENZYME TEST LD-1
Chemistry
73d
Cleared
Mar 05, 1985
ISOCONTROL SERUM CK-MB
Chemistry
49d
Cleared
Feb 07, 1985
ISOCONTROL SERUM LD-
Chemistry
23d
Cleared
Feb 07, 1985
ISOENZYME TEST CK-MB
Chemistry
23d
Cleared
Oct 05, 1984
SCLAVO CHLORIDE TEST
Chemistry
10d
Cleared
Sep 14, 1984
INORGANIC PHOSPHORUS TEST
Chemistry
32d
Cleared
Sep 07, 1984
TOTAL BILIRUBIN TEST
Chemistry
25d
Cleared
Sep 07, 1984
CREATININE TEST
Chemistry
25d
Cleared
Mar 23, 1984
UNI-FAST ANALYZER SYSTEM
Chemistry
72d
Cleared
Mar 19, 1984
BLOOD UREA NITROGEN REAGENT SYS
Chemistry
60d
Cleared
Mar 19, 1984
CALCIUM REAGENT SYS
Chemistry
60d
Cleared
Mar 19, 1984
PHOSPHORUS REAGENT SYSTEM
Chemistry
60d
Cleared
Mar 19, 1984
SODIUM/POTASSIUM REAGENT SYS
Chemistry
60d
Cleared
Jul 07, 1983
AMYLAST-D TEST
Chemistry
52d
Cleared
Jul 06, 1983
GLUCOSE HEXOKINASE DIAG. KIT
Chemistry
51d
Cleared
Feb 25, 1983
TRIGLYCERIDE DIAGNOSTIC KIT
Chemistry
29d
Cleared
Jan 28, 1983
TOTAL IRON BINDING CAPACITY TEST
Chemistry
21d
Cleared
Jan 28, 1983
SERUM IRON DIAGNOSTIC TEST KITS
Chemistry
17d
Cleared
Oct 21, 1982
NEW ENZYMATIC SINGLE REAGENT FREE CHOL.
Chemistry
71d
Cleared
Aug 16, 1982
C-REACTIVE PROTEIN TEST KIT
Chemistry
12d
Cleared
Aug 12, 1981
FAST CHOLES-CINET
Chemistry
20d