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510(k) K052053

LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK by Bio-Rad — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2005
Date Received
July 29, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Mixture Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

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