Preview Digital Pregnancy Test
FDA 510(k) clearance K173229 · decided 2018-03-12
Clearance details
- K-number
- K173229
- Device name
- Preview Digital Pregnancy Test
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-10-04
- Decision date
- 2018-03-12
- Days to decision
- 159 days
- Clearance type
- Traditional
- Product code
- LCX
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Guangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.