510(k) K822866
K822866 is an FDA 510(k) premarket notification submitted by Lilly Research Laboratories for the device "MOXALACTAM". The FDA issued a decision of Substantially Equivalent on December 28, 1982. The device falls under product code JTT (Susceptibility Test Powders, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. Lilly Research Laboratories has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 28, 1982
- Date Received
- September 27, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Susceptibility Test Powders, Antimicrobial
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type