510(k) K053236
K053236 is an FDA 510(k) premarket notification submitted by Runbio Biotech Co.,Ltd for the device "DAVID PREGNANCY TEST (MIDSTREAM)". The FDA issued a decision of Substantially Equivalent on Jul 18, 2006. 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
- Jul 18, 2006
- Date Received
- Nov 18, 2005
- 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)