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) clearance K172257 · decided 2017-12-22
Clearance details
- 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)
- Applicant
- True Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-07-26
- Decision date
- 2017-12-22
- Days to decision
- 149 days
- Clearance type
- Traditional
- Product code
- JHI
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.