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510(k) K043051

QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 by Phamatech, Inc. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2005
Date Received
November 4, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

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  • K040575 — PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 (May 20, 2004)
  • K030447 — AT HOME DRUG CUP, MODEL 9150X (April 14, 2003)

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