Home / 510(k) Clearances / K974059

510(k) K974059

ONE STEP MIDSTREAM HCG PREGNANCY TEST by International Newtech Development, Inc. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1998
Date Received
October 27, 1997
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 International Newtech Development, Inc.

  • K993850 — URINALYSIS REAGENT STRIPS (10 PARAMETERS) (January 3, 2000)
  • K974060 — MINISTRIP/ SERUM AND URINE COMBO HCG TEST (April 9, 1998)
  • K974009 — PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG (March 13, 1998)
  • K970176 — HCG CONTROLS (February 6, 1997)
  • K963133 — PS-UNIT CASSETTE/SERUM HCG (November 18, 1996)
  • K963132 — MINI STRIP/SERUM HCG (November 18, 1996)
  • K951705 — MINISTRIP HCG (October 3, 1995)

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)