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510(k) K880478

PREGNANCY BETA-HCG CARD & LIQUID TEST by Ampcor, Inc. — Product Code JHJ

K880478 is an FDA 510(k) premarket notification submitted by Ampcor, Inc. for the device "PREGNANCY BETA-HCG CARD & LIQUID TEST". The FDA issued a decision of Substantially Equivalent on April 28, 1988. The device falls under product code JHJ (Agglutination Method, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Ampcor, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1988
Date Received
February 4, 1988
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 Ampcor, Inc.

  • K922297 — INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST (July 14, 1992)
  • K922296 — IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST (July 14, 1992)
  • K910438 — DIPSTICK SALMONELLA (September 13, 1991)
  • K893873 — SINGLE AND DUAL BAND DIPSTICK HCG TEST (August 21, 1989)
  • K890048 — QUIK-DOT TOXOPLASMOSIS (June 9, 1989)
  • K892119 — QUIK-DOT C REACTIVE PROTEIN (April 14, 1989)
  • K892146 — C REACTIVE PROTEIN LIQUID (April 14, 1989)
  • K890025 — QUIK-DOT ANTISTREPTOLYSIN-O (January 31, 1989)
  • K884750 — GROUP A STREP, BETA-STREP (December 22, 1988)
  • K880163 — PREGNANCY (HCG) CARD & LIQUID TEST (May 17, 1988)

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)
  • K880328 — HCG-NOSTICK (March 15, 1988)

FDA data resources