510(k) K070172
K070172 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corporation for the device "AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE". The FDA issued a decision of Substantially Equivalent on April 17, 2007. The device falls under product code LSL (Dna-Reagents, Neisseria), a Class II device regulated under 21 CFR 866.3390. Roche Diagnostics Corporation has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2007
- Date Received
- January 18, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dna-Reagents, Neisseria
- Device Class
- Class II
- Regulation Number
- 866.3390
- Review Panel
- MI
- Submission Type