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510(k) K980331

IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S by More Diagnostics — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1998
Date Received
January 28, 1998
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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