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510(k) K120504

LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK by Bio-Rad Laboratories, Inc. — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2012
Date Received
February 21, 2012
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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