The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Gen Diagnostics' Imipenem 10 Mcg Susceptibity Disk.
| Device ID | K860031 |
| 510k Number | K860031 |
| Device Name: | GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK |
| Classification | Susceptibility Test Powders, Antimicrobial |
| Applicant | ORGANON TEKNIKA CORP. 201 TABOR RD. Morris Plains, NJ 07950 |
| Contact | Lynn Decaro |
| Correspondent | Lynn Decaro ORGANON TEKNIKA CORP. 201 TABOR RD. Morris Plains, NJ 07950 |
| Product Code | JTT |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-06 |
| Decision Date | 1986-03-06 |