510(k) K231329
K231329 is an FDA 510(k) premarket notification submitted by Hologic, Inc. for the device "Aptima Neisseria gonorrhoeae Assay". The FDA issued a decision of Substantially Equivalent on January 26, 2024. The device falls under product code LSL (Dna-Reagents, Neisseria), a Class II device regulated under 21 CFR 866.3390. Hologic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 2024
- Date Received
- May 8, 2023
- 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