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510(k) K910881

CONTROL AND LINEARITY by Gds Diagnostics — Product Code DKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1991
Date Received
March 1, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Mixture
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

Other clearances by Gds Diagnostics

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  • K910108 — GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED (March 4, 1991)
  • K891761 — GDS ENZYMATIC THEOPHYLLINE REAGENT (May 16, 1989)

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