510(k) K860498
K860498 is an FDA 510(k) premarket notification submitted by Gen-Probe, Inc. for the device "GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM". The FDA issued a decision of Substantially Equivalent on July 16, 1986. The device falls under product code LQH (Dna-Reagents, Legionella), a Class II device regulated under 21 CFR 866.3300. Gen-Probe, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 1986
- Date Received
- February 10, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dna-Reagents, Legionella
- Device Class
- Class II
- Regulation Number
- 866.3300
- Review Panel
- MI
- Submission Type