The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Cefotetan 30 Mcg Antimicrobial Susceptibility Disk.
| Device ID | K860895 |
| 510k Number | K860895 |
| Device Name: | CEFOTETAN 30 MCG ANTIMICROBIAL SUSCEPTIBILITY DISK |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | ORGANON TEKNIKA CORP. 201 TABOR RD. Morris Plains, NJ 07950 |
| Contact | Vivian Devita |
| Correspondent | Vivian Devita ORGANON TEKNIKA CORP. 201 TABOR RD. Morris Plains, NJ 07950 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-10 |
| Decision Date | 1986-04-11 |