510(k) K810427
K810427 is an FDA 510(k) premarket notification submitted by Pfizer Pharmaceuticals for the device "CEFOTAXIME 30MCG ANTIMICROBIAL SUSCEP.". The FDA issued a decision of Substantially Equivalent on March 31, 1981. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Pfizer Pharmaceuticals has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 1981
- Date Received
- February 18, 1981
- 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