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510(k) K853141

ACCESS DIGIWIPE SYSTEM by Medtech Products, Inc. — Product Code KHE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1985
Date Received
July 24, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Occult Blood
Device Class
Class II
Regulation Number
864.6550
Review Panel
HE
Submission Type

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