DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette
FDA 510(k) clearance K181551 · decided 2019-02-22
Clearance details
- K-number
- K181551
- Device name
- DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette
- Applicant
- Runbio Biotech Co.,Ltd
- Decision
- Substantially Equivalent
- Date received
- 2018-06-13
- Decision date
- 2019-02-22
- Days to decision
- 254 days
- Clearance type
- Traditional
- Product code
- LCX
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Shantou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.