510(k) K033861
K033861 is an FDA 510(k) premarket notification submitted by Becton, Dickinson & CO for the device "BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY". The FDA issued a decision of Substantially Equivalent on March 9, 2004. The device falls under product code LQH (Dna-Reagents, Legionella), a Class II device regulated under 21 CFR 866.3300. Becton, Dickinson & CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 2004
- Date Received
- December 12, 2003
- 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