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510(k) K781794

BETA-TEC by Wampole Laboratories — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1978
Date Received
October 25, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Visual, Pregnancy Hcg, Prescription Use
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

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