510(k) K851271
K851271 is an FDA 510(k) premarket notification submitted by Gen-Probe, Inc. for the device "LEGIONELLA CULTURE CONFIRMATIN KIT". The FDA issued a decision of Substantially Equivalent on July 8, 1985. The device falls under product code GRO (Antisera, Fluorescent, All Types, Hemophilus Spp.), 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 8, 1985
- Date Received
- April 1, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Fluorescent, All Types, Hemophilus Spp.
- Device Class
- Class II
- Regulation Number
- 866.3300
- Review Panel
- MI
- Submission Type