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510(k) K013101

WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA by Wiener Laboratories Saic — Product Code JFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2001
Date Received
September 17, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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