Home / 510(k) Clearances / K902208

510(k) K902208

MODIFIED OVUGEN by Biogenex Laboratories — Product Code CEP

K902208 is an FDA 510(k) premarket notification submitted by Biogenex Laboratories for the device "MODIFIED OVUGEN". The FDA issued a decision of Substantially Equivalent on July 17, 1990. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Biogenex Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1990
Date Received
May 16, 1990
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 Biogenex Laboratories

  • K012960 — BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR (March 8, 2002)
  • K013148 — BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) (February 28, 2002)
  • K925189 — PREGNAGEN 1-STEP PREGNANCY TEST (January 6, 1993)
  • K884880 — PREGNAGEN(TM) (January 13, 1989)
  • K882002 — PREGNAGEN(TM) (September 9, 1988)
  • K873534 — OVUGEN SURETEST (November 23, 1987)
  • K831221 — RIAGEN B-HCG RIA KIT (June 2, 1983)
  • K821657 — RIAGEN B-HCG RIA (July 13, 1982)
  • K821234 — RIAGEN B-HCG RIA (May 21, 1982)
  • K820724 — FLUOROGEN PAP FIA (April 14, 1982)

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)
  • K991466 — EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), O (May 25, 1999)
  • K991386 — EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATI (May 25, 1999)

FDA data resources