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510(k) K951494

AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) by Emd Chemicals, Inc. — Product Code CIJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1995
Date Received
March 31, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saccharogenic, Amylase
Device Class
Class II
Regulation Number
862.1070
Review Panel
CH
Submission Type

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