Home / 510(k) Clearances / K023126

510(k) K023126

AMEDITECH IMMUTEST HCG PREGANCY TEST by Ameditech, Inc. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2002
Date Received
September 19, 2002
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 Ameditech, Inc.

  • K113501 — AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) (December 5, 2011)
  • K113046 — AMEDITECH IMMUTEST MILTI-DRUG SCREEN (November 10, 2011)
  • K063015 — AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 (December 20, 2006)
  • K053175 — AMEDITECH DRUGSMARTCUP (December 8, 2005)
  • K050186 — AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III (March 4, 2005)
  • K042975 — AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II (December 29, 2004)
  • K040092 — AMEDITECH IMMU TEST DRUG SCREEN PANEL (March 8, 2004)
  • K012582 — AMEDITECH IMMUTEST DRUG SCREEN PCP (November 30, 2001)
  • K012484 — AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE (November 30, 2001)
  • K012483 — AMEDITECH IMMUTEST DRUG SCREEN OPIATES (November 30, 2001)

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)