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510(k) K882038

GDS ENZYMATIC SALICYLATE REAGENT by Gds Technology, LLC — Product Code DKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1988
Date Received
May 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetry, Salicylate
Device Class
Class II
Regulation Number
862.3830
Review Panel
TX
Submission Type

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