The following data is part of a premarket notification filed by Pfizer Pharmaceuticals with the FDA for Cefotaxime 30mcg Antimicrobial Suscep..
| Device ID | K810427 |
| 510k Number | K810427 |
| Device Name: | CEFOTAXIME 30MCG ANTIMICROBIAL SUSCEP. |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | PFIZER PHARMACEUTICALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-18 |
| Decision Date | 1981-03-31 |