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510(k) K884880

PREGNAGEN(TM) by Biogenex Laboratories — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1989
Date Received
November 21, 1988
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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  • K925189 — PREGNAGEN 1-STEP PREGNANCY TEST (January 6, 1993)
  • K902208 — MODIFIED OVUGEN (July 17, 1990)
  • 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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  • K152768 — Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregn (February 24, 2016)
  • K130456 — WUNDER PREGNANCY TEST (April 8, 2014)
  • K132834 — FASTEP S10 HCG SERUM/URINE COMBO TEST (January 9, 2014)
  • K131166 — SOFIA(R) HCG FIA (August 2, 2013)
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  • K112101 — FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS (July 17, 2012)