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510(k) K091846

SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 by Beckman Coulter, Inc. — Product Code JFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2009
Date Received
June 22, 2009
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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  • K062180 — ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM (October 2, 2006)
  • K051447 — SENTINEL PANCREATIC AMYLASE (January 26, 2006)
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