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510(k) K021393

PRECISET DAT PLUS by Quantimetrix Corp. — Product Code DKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2002
Date Received
May 2, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Mixture
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

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