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510(k) K821657

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1982
Date Received
June 4, 1982
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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  • K884880 — PREGNAGEN(TM) (January 13, 1989)
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  • K873534 — OVUGEN SURETEST (November 23, 1987)
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  • K821234 — RIAGEN B-HCG RIA (May 21, 1982)
  • K820724 — FLUOROGEN PAP FIA (April 14, 1982)

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