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510(k) K843601

ACCESS HEMAWIPE by Medtech Products, Inc. — Product Code KHE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1985
Date Received
September 12, 1984
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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