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510(k) K242576

AllTest Viral Transport Medium by Hangzhou AllTest Biotech Co., Ltd. — Product Code JSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2025
Date Received
August 29, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Propagating Transport
Device Class
Class I
Regulation Number
866.2390
Review Panel
MI
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)
  • K241978 — Shinetell Digital Pregnancy Test (August 13, 2024)
  • K241428 — AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup (June 17, 2024)
  • K233019 — AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest (December 13, 2023)
  • K233417 — AllTest Fentanyl Urine Test Cassette (October 26, 2023)
  • K231698 — AllTest Fentanyl Rapid Test (Urine) (July 31, 2023)

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  • K232454 — Viral Transport Media (VTM) (May 3, 2024)
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