510(k) K781489

ACID PHOSPHATASE DIAG. KIT by Sclavo, Inc. — Product Code CJN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1978
Date Received
August 28, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid Phosphatase, Nitrophenylphosphate
Device Class
Class II
Regulation Number
862.1020
Review Panel
CH
Submission Type