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510(k) K871726

OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) by Monoclonal Antibodies, Inc. — Product Code CEP

K871726 is an FDA 510(k) premarket notification submitted by Monoclonal Antibodies, Inc. for the device "OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)". The FDA issued a decision of Substantially Equivalent on July 27, 1987. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Monoclonal Antibodies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1987
Date Received
May 5, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Luteinizing Hormone
Device Class
Class I
Regulation Number
862.1485
Review Panel
CH
Submission Type

Other clearances by Monoclonal Antibodies, Inc.

  • K874863 — RAMP HERPES SIMPLEX VIRUS (HSV) (CCT) (February 16, 1988)
  • 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)
  • K840738 — PLUS URINE HCG ASSAY (April 19, 1984)
  • K840412 — OVU STICK URINE HLH KIT (April 13, 1984)
  • K833504 — PREGNASTICK URINE HCG KIT (January 9, 1984)

Other clearances for product code CEP

  • K013582 — MAYBE?MOM MINI OVULATION MICROSCOPE (January 16, 2003)
  • K022829 — INSTANT-VIEW LH OVULATION PREDICTING TEST (November 5, 2002)
  • K021409 — AT HOME OVULATION TEST, MODEL 9032 (May 24, 2002)
  • K013874 — CLEARPLANE EASY OVULATION TEST (February 19, 2002)
  • K013323 — TCI-31 LIFELONG OVULATION TESTER (December 5, 2001)
  • K012252 — QUIK-CHECK OVULATION PREDICTOR (August 24, 2001)
  • K010244 — SURE CHECK OVULATION PREDICTOR (May 2, 2001)
  • K002867 — INVERNESS MEDICAL OVULATION PREDICTOR TEST (October 12, 2000)
  • K991386 — EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATI (May 25, 1999)
  • K991466 — EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), O (May 25, 1999)

FDA data resources