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510(k) K040920

AMYLASE LIQUID REAGENT, MODEL A532-200 by Teco Diagnostics — Product Code JFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2004
Date Received
April 8, 2004
Clearance Type
Special
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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  • K051447 — SENTINEL PANCREATIC AMYLASE (January 26, 2006)