Home / 510(k) Clearances / K990249

510(k) K990249

OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 by Phamatech — Product Code CEP

K990249 is an FDA 510(k) premarket notification submitted by Phamatech for the device "OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031". The FDA issued a decision of Substantially Equivalent on March 22, 1999. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Phamatech has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1999
Date Received
January 26, 1999
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

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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