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510(k) K072257

MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL by More Diagnostics — Product Code LAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2008
Date Received
August 13, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K970517 — INNOFLUOR TOPIRAMATE CONTROL SET (May 12, 1997)
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  • K946119 — ROCHE-TDM ONLEIN(TM) CONTROLS (February 7, 1995)