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510(k) K943241

DMA GLUCOSE (OXIDASE) PROCEDURE by Data Medical Associates, Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1994
Date Received
July 6, 1994
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

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  • K946354 — DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE (May 8, 1995)
  • K946355 — DMA ALBUMIN PROCEDURE (March 1, 1995)

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