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510(k) K883530

FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST by Tambrands, Inc. — Product Code CEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1988
Date Received
August 18, 1988
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 Tambrands, Inc.

  • K962476 — UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR (August 13, 1996)
  • K960341 — TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS (April 17, 1996)
  • K952344 — SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS (July 28, 1995)
  • K944834 — UNSCENTED MENSTRUAL TAMPONS (December 21, 1994)
  • K924303 — TAMPAX TAMPON, REGULAR ABSORBENCY (July 29, 1993)
  • K923932 — TAMPAX TAMPONS, SUPER ABSORBENCY (July 29, 1993)
  • K896989 — TAMPAX TAMPON (December 22, 1989)
  • K896113 — TAMPON, PETAL SOFT PLASTIC APPLICATOR, SUPER PLUS (December 13, 1989)
  • K896112 — TAMPAX TAMPON, FLUSHABLE APPLICATOR, SUPER PLUS (December 13, 1989)
  • K896115 — TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPER (December 13, 1989)

Other clearances for product code CEP

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  • 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)