Sclavo, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
82
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K914789ELISA CMV IGMMarch 4, 1992
K914852ELISA TOXO IGMJanuary 23, 1992
K914420ELISA RUBELLA IGMDecember 27, 1991
K895943NORMAL AND ABNORMAL CONTROL SERADecember 27, 1989
K895822TOTAL BILIRUBIN L.F.November 14, 1989
K895847CREATININE 340 (ENZYMATIC)October 30, 1989
K880199CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATEJanuary 27, 1989
K880049CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATEJanuary 27, 1989
K873496ATYPICAL CHOLINESTERASEJanuary 27, 1989
K884035SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZERDecember 29, 1988
K884649TOTAL IRON BINDING CAPACITY TESTDecember 14, 1988
K882325UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TESTAugust 25, 1988
K881381REAGENTS FOR TSH ASSAYJuly 21, 1988
K881214IMMPULSE T, ASSAY REAGENTSMay 27, 1988
K881204ACP KINETIC TEST (ACID PHOSPHATASE TEST)April 28, 1988
K881202IRON TESTApril 28, 1988
K880016MODIFIED CRP LATEX TESTFebruary 25, 1988
K874748IMMPULSE DIGOXIN ASSAY REAGENTSFebruary 19, 1988
K875081IMMPULSE T4 ASSAY REAGENTSFebruary 11, 1988
K873297DIFFERENTIAL I.M. SCREENING TESTDecember 14, 1987