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510(k) K925189

PREGNAGEN 1-STEP PREGNANCY TEST by Biogenex Laboratories — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1993
Date Received
October 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

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  • K902208 — MODIFIED OVUGEN (July 17, 1990)
  • K884880 — PREGNAGEN(TM) (January 13, 1989)
  • K882002 — PREGNAGEN(TM) (September 9, 1988)
  • K873534 — OVUGEN SURETEST (November 23, 1987)
  • K831221 — RIAGEN B-HCG RIA KIT (June 2, 1983)
  • K821657 — RIAGEN B-HCG RIA (July 13, 1982)
  • K821234 — RIAGEN B-HCG RIA (May 21, 1982)
  • K820724 — FLUOROGEN PAP FIA (April 14, 1982)

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