510(k) K852689
K852689 is an FDA 510(k) premarket notification submitted by Warner-Lambert Co. for the device "GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK". The FDA issued a decision of Substantially Equivalent on August 19, 1985. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Warner-Lambert Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 1985
- Date Received
- June 25, 1985
- 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