510(k) K970212
K970212 is an FDA 510(k) premarket notification submitted by Becton Dickinson Microbiology Systems for the device "LEVOFLOXACIN, 5MCG, SENSI-DISC". The FDA issued a decision of Substantially Equivalent on Mar 6, 1997. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Becton Dickinson Microbiology Systems has 32 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 6, 1997
- Date Received
- Jan 21, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Susceptibility Test Discs, Antimicrobial
- Device Class
- Class II
- Regulation Number
- 866.1620
- Review Panel
- MI
- Submission Type
- 510(k)