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510(k) K831221

RIAGEN B-HCG RIA KIT by Biogenex Laboratories — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1983
Date Received
April 15, 1983
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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