510(k) K172627
K172627 is an FDA 510(k) premarket notification submitted by Runbio Biotech Co.,Ltd for the device "David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette". The FDA issued a decision of Substantially Equivalent on Mar 28, 2018. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Runbio Biotech Co.,Ltd has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 28, 2018
- Date Received
- Sep 1, 2017
- 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
- 510(k)