Sclavo, Inc. - FDA 510(k) Cleared Devices
82
Total
82
Cleared
0
Denied
82 devices
Cleared
Sep 04, 1987
UNIFAST GAMMA-GT
Chemistry
25d
Cleared
Aug 27, 1987
PROTHROMBIN TIME TEST
Hematology
63d
Cleared
Jul 07, 1987
UNI-FAST LACTATE DEHYDROGENASE (LDH-L)
Chemistry
42d
Cleared
Jun 17, 1987
UNI-FAST CREATINE KINASE TEST (CK)
Chemistry
22d
Cleared
Apr 29, 1987
CALCIUM TEST
Chemistry
75d
Cleared
Apr 22, 1987
CHLORIDE TEST
Chemistry
68d
Cleared
Mar 13, 1987
FAST GLUCOSE
Chemistry
28d
Cleared
Mar 13, 1987
FAST URIC ACID
Chemistry
28d
Cleared
Feb 06, 1987
IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS
Toxicology
46d
Cleared
Feb 04, 1987
UNIFAST CALCIUM TEST
Chemistry
68d
Cleared
Jan 13, 1987
IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS
Toxicology
20d
Cleared
Dec 22, 1986
IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS
Toxicology
42d
Cleared
Dec 03, 1986
IMMPULSE IGE ASSAY REAGENTS
Immunology
98d
Cleared
Sep 29, 1986
POTASSIUM TEST
Chemistry
20d
Cleared
Jul 16, 1986
FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST)
Chemistry
15d
Cleared
Jul 16, 1986
IMMPULSE PHENOBARBITAL ASSAY REAGENTS
Toxicology
14d
Cleared
Jul 16, 1986
IMMPULSE PHENYTOIN ASSAY REAGENT
Toxicology
13d
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
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