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510(k) K232864

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II by Nantong Egens Biotechnology Co., Ltd. — Product Code LCX

K232864 is an FDA 510(k) premarket notification submitted by Nantong Egens Biotechnology Co., Ltd. for the device "EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II". The FDA issued a decision of Substantially Equivalent on January 26, 2024. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2024
Date Received
September 15, 2023
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

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  • 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)

FDA data resources