510(k) K003395
K003395 is an FDA 510(k) premarket notification submitted by Gen-Probe, Inc. for the device "GEN-PROBE APTIMA COMBO 2 ASSAY". The FDA issued a decision of Substantially Equivalent on May 21, 2001. The device falls under product code LSL (Dna-Reagents, Neisseria), a Class II device regulated under 21 CFR 866.3390. Gen-Probe, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 2001
- Date Received
- November 1, 2000
- 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