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510(k) K880829

GDS ENZYMATIC ACETAMINOPHEN REAGENT by Gds Technology, LLC — Product Code LDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1988
Date Received
March 1, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetry, Acetaminophen
Device Class
Class II
Regulation Number
862.3030
Review Panel
TX
Submission Type

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Other clearances for product code LDP

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  • K043242 — TRIAGE TOX DRUG SCREEN (February 28, 2005)
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  • K020792 — ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (July 11, 2002)
  • K013757 — ROCHE ACETAMINOPHEN (January 8, 2002)