Home / 510(k) Clearances / K123436

510(k) K123436

FIRST RESPONSE EARLY RESULT PREGNANCY TEST by Church & Dwight Co., Inc. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2013
Date Received
November 7, 2012
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 Church & Dwight Co., Inc.

  • K243640 — Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed E (February 21, 2025)
  • K240379 — TROJAN SIS Synthetic Latex Condom with Silicone Lubricant (October 8, 2024)
  • K221906 — TROJAN Fire & Ice lubricated male natural rubber latex condom (September 28, 2022)
  • K221431 — TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lu (July 14, 2022)
  • K203818 — Replens Long-Lasting Vaginal Moisturizer (June 11, 2021)
  • K193450 — Pre-Seed™ Fertility Lubricant (July 23, 2020)
  • K180764 — TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) (August 1, 2018)
  • K180104 — Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant (March 14, 2018)
  • K171639 — Trojan Supra Lubricated Polyurethane Male Condom (August 1, 2017)
  • K161915 — Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubri (September 9, 2016)

Other clearances for product code LCX

  • K251040 — MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital P (September 9, 2025)
  • K251053 — Shinetell PlusTM Digital Early Pregnancy Test (July 15, 2025)
  • K250117 — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette (February 13, 2025)
  • K242135 — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synth (January 31, 2025)
  • K243573 — FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Casse (January 15, 2025)
  • K241394 — iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip (December 20, 2024)
  • K240242 — HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test (October 11, 2024)
  • K241978 — Shinetell Digital Pregnancy Test (August 13, 2024)
  • K240643 — MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnanc (June 21, 2024)
  • K232715 — Distinct® Digital Pregnancy Test (May 31, 2024)