510(k) K132251
K132251 is an FDA 510(k) premarket notification submitted by Hologic / Gen-Probe Incorporated for the device "APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)". The FDA issued a decision of Substantially Equivalent on October 17, 2013. The device falls under product code LSL (Dna-Reagents, Neisseria), a Class II device regulated under 21 CFR 866.3390.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 2013
- Date Received
- July 19, 2013
- 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