510(k) K981517
K981517 is an FDA 510(k) premarket notification submitted by Becton Dickinson Microbiology Systems for the device "CEFDINIR, 5 UG, SENSI-DISC". The FDA issued a decision of Substantially Equivalent on June 9, 1998. 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 at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 1998
- Date Received
- April 28, 1998
- 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