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510(k) K072721

LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC by Bio-Rad, Diagnostics Grp. — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2007
Date Received
September 26, 2007
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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  • K093577 — LIQUICHEK OPIATE CONTROL (March 12, 2010)
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