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510(k) K810669

PANTRAK E.K. by Calbiochem-Behring Corp. — Product Code CIW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1981
Date Received
March 12, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Starch-Dye Bound Polymer, Amylase
Device Class
Class II
Regulation Number
862.1070
Review Panel
CH
Submission Type

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