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510(k) K840738

PLUS URINE HCG ASSAY by Monoclonal Antibodies, Inc. — Product Code JHJ

K840738 is an FDA 510(k) premarket notification submitted by Monoclonal Antibodies, Inc. for the device "PLUS URINE HCG ASSAY". The FDA issued a decision of Substantially Equivalent on April 19, 1984. The device falls under product code JHJ (Agglutination Method, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Monoclonal Antibodies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1984
Date Received
February 21, 1984
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 Monoclonal Antibodies, Inc.

  • K874863 — RAMP HERPES SIMPLEX VIRUS (HSV) (CCT) (February 16, 1988)
  • K871726 — OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) (July 27, 1987)
  • K863744 — HCG CONTROL KIT (November 5, 1986)
  • K860924 — RAMP PROGESTURINE PDG ASSAY--48 TEST KIT (July 2, 1986)
  • K854611 — RAMP URINE HCG ASSAY (December 30, 1985)
  • K850730 — MODEL SERUM HCG ASSAY (April 2, 1985)
  • K850480 — OVU STICK SELF-TEST -MODIFICATION (March 5, 1985)
  • K843284 — OVUSTICK SELF-TEST (December 11, 1984)
  • K840412 — OVU STICK URINE HLH KIT (April 13, 1984)
  • K833504 — PREGNASTICK URINE HCG KIT (January 9, 1984)

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