Home / 510(k) Clearances / K810581

510(k) K810581

FACT* HOME PREGNANCY TEST by Ortho Pharmaceutical Corp. — Product Code JHJ

K810581 is an FDA 510(k) premarket notification submitted by Ortho Pharmaceutical Corp. for the device "FACT* HOME PREGNANCY TEST". The FDA issued a decision of Substantially Equivalent on March 17, 1981. The device falls under product code JHJ (Agglutination Method, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Ortho Pharmaceutical Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1981
Date Received
March 3, 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 Ortho Pharmaceutical Corp.

  • K955648 — K-Y PERSONAL LUBRICANT (June 21, 1996)
  • K934516 — ADVANCE PREGNANCY TEST MODIFICATION (February 24, 1994)
  • K914990 — ADVANCE(R) PREGNANCY TEST (December 23, 1991)
  • K893488 — PULSATILE PUMP FOR GONADORELIN ACETATE (October 31, 1989)
  • K881151 — MICROSCRAPE (April 6, 1988)
  • K800754 — NICKERSON'S MED. SELECTIVE CULTURE MEDIU (April 29, 1980)
  • K792634 — CONCEPTROL/THIN PROPHYLACTICS (January 16, 1980)
  • K790087 — LUBRICANT, OTRHO PERSONAL (February 1, 1979)

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)

FDA data resources