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510(k) K811940

OREIA II, B-HCG by Organon, Inc. — Product Code JHJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1981
Date Received
July 6, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agglutination Method, Human Chorionic Gonadotropin
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)
  • K832801 — OREIA II B-HCG, ENZYME INNUNOASSAY (December 8, 1983)
  • K831339 — NEO-PREGNOSTICON DUOCLON TUBE TEST (June 8, 1983)
  • K831109 — DUOCLON SLIDE TEST (June 2, 1983)
  • K823682 — BETA FFIRM TEST (January 7, 1983)

Other clearances for product code JHJ

  • K972606 — PREGNACOL PREGNANCY TEST (August 29, 1997)
  • K921968 — IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST (June 28, 1996)
  • K935863 — SAS(TM) DIRECT MONOCLONAL HCG (February 24, 1994)
  • K926112 — ACCUTEX BETA-HCG TEST (July 28, 1993)
  • K930609 — SAS(TM) MONOCLONAL HCG-SLIDE (March 29, 1993)
  • K920716 — DIRECT PREGNANCY TEST (March 24, 1992)
  • K910946 — CLEARVIEW HCG (April 1, 1991)
  • K881435 — PREGNOSPIA II (May 27, 1988)
  • K880163 — PREGNANCY (HCG) CARD & LIQUID TEST (May 17, 1988)
  • K880478 — PREGNANCY BETA-HCG CARD & LIQUID TEST (April 28, 1988)