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510(k) K880585

DEXPAD, BLOOD GLUCOSE STRIP by Mach Diag. C/O Wichita State University — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1988
Date Received
February 10, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Mach Diag. C/O Wichita State University

  • K880584 — URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C (May 31, 1988)

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