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FDA 510(k), K172257, TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
FDA 510(k), K172257, TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
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$149.00 USD
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Sale price
$149.00 USD
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510(K) Number: K172257
Device Name: TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
Manufacturer: True Diagnostics, Inc
Device Classification Name: visual, pregnancy hcg, prescription use
Regulation Number: 862.1155
Classification Product Code: JHI
Date Received: 07/26/2017
Decision Date: 12/22/2017
Regulation Medical Specialty: Clinical Chemistry
Device Name: TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
Manufacturer: True Diagnostics, Inc
Device Classification Name: visual, pregnancy hcg, prescription use
Regulation Number: 862.1155
Classification Product Code: JHI
Date Received: 07/26/2017
Decision Date: 12/22/2017
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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