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510(k) K041578

QUICKSCREEN, MODELS 9177X AND 9178X by Phamatech — Product Code LCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2004
Date Received
June 14, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Phencyclidine
Device Class
Class U
Regulation Number
Review Panel
TX
Submission Type

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  • K030447 — AT HOME DRUG CUP, MODEL 9150X (April 14, 2003)

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