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510(k) K202453

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card by Safecare Biotech (Hangzhou) Co., Ltd. — Product Code NFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2021
Date Received
August 27, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Amphetamine, Over The Counter
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by Safecare Biotech (Hangzhou) Co., Ltd.

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  • K200133 — hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream (August 13, 2020)
  • K201120 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card (May 27, 2020)
  • K191924 — SAFECARE® THC Urine Strip Test (August 16, 2019)
  • K182654 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card (November 19, 2018)
  • K181968 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card (August 20, 2018)
  • K153646 — SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Tes (March 18, 2016)

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