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510(k) K832801

OREIA II B-HCG, ENZYME INNUNOASSAY by Organon, Inc. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1983
Date Received
August 18, 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

Other clearances by Organon, Inc.

  • K950861 — RECONSTITUTION ACCESSOREIS (May 26, 1995)
  • K853388 — MONOSTICON UNI-DOT (August 22, 1985)
  • K842314 — DUOCLON COLOR-CEPT (August 24, 1984)
  • K841525 — OREIA II B-HCG PREGNANCY TEST KIT (June 5, 1984)
  • K841602 — ACCURATE BETA 30 PREGNANCY TEST KIT (May 22, 1984)
  • K840650 — B-NEOCEPT 30 (April 4, 1984)
  • K831339 — NEO-PREGNOSTICON DUOCLON TUBE TEST (June 8, 1983)
  • K831109 — DUOCLON SLIDE TEST (June 2, 1983)
  • K823682 — BETA FFIRM TEST (January 7, 1983)
  • K812967 — ACCURATE BETA (November 6, 1981)

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  • K130456 — WUNDER PREGNANCY TEST (April 8, 2014)
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  • 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)