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510(k) K251053

Shinetell PlusTM Digital Early Pregnancy Test by Hangzhou AllTest Biotech Co., Ltd. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2025
Date Received
April 4, 2025
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 Hangzhou AllTest Biotech Co., Ltd.

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  • K244043 — AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup (February 27, 2025)
  • K242540 — AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel (September 27, 2024)
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  • K241428 — AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup (June 17, 2024)
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  • K233417 — AllTest Fentanyl Urine Test Cassette (October 26, 2023)
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Other clearances for product code LCX

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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)
  • K233624 — HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG (April 12, 2024)