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510(k) K991386

EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) by Selfcare, Inc. — Product Code CEP

K991386 is an FDA 510(k) premarket notification submitted by Selfcare, Inc. for the device "EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)". The FDA issued a decision of Substantially Equivalent on May 25, 1999. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Selfcare, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1999
Date Received
April 21, 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

Other clearances by Selfcare, Inc.

  • K002867 — INVERNESS MEDICAL OVULATION PREDICTOR TEST (October 12, 2000)
  • K002134 — ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM (August 7, 2000)
  • K002049 — INVERNESS MEDICAL EARLY PREGNANCY TEST (July 27, 2000)
  • K001427 — MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (June 2, 2000)
  • K000583 — FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (March 17, 2000)
  • K993632 — FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (November 12, 1999)
  • K991480 — EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP (September 17, 1999)
  • K991466 — EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), O (May 25, 1999)
  • K990939 — FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (April 20, 1999)
  • K983468 — FASTTAKE ADAPTER, MODEL # P/N 020-072-01 (December 17, 1998)

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)
  • K990249 — OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MOD (March 22, 1999)

FDA data resources