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510(k) K012318

RANDOX THERAPEUTIC DRUG CALIBRATOR by Randox Laboratories, Ltd. — Product Code DKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2001
Date Received
July 23, 2001
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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