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510(k) K182328

VeriClear Digital Early Result Pregnancy Test by True Diagnostics, Inc. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2019
Date Received
August 27, 2018
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 True Diagnostics, Inc.

  • K172257 — TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Resu (December 22, 2017)

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