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510(k) K840214

CALCIUM REAGENT SYS by Sclavo, Inc. — Product Code CHZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1984
Date Received
January 19, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Di (O-Hydroxyphenylimine) Ethane, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

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