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510(k) K042865

LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) by Bio-Rad — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2004
Date Received
October 18, 2004
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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