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510(k) K874823

FIRST RESPONSE 5 MINUTE PREGNANCY TEST by Tambrands, Inc. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1988
Date Received
November 24, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class
Class II
Regulation Number
862.1155
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)
  • K923932 — TAMPAX TAMPONS, SUPER ABSORBENCY (July 29, 1993)
  • K924303 — TAMPAX TAMPON, REGULAR 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)

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