The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Ticarcillin/clvulinic Acid 85 Mcg Susceptibility D.
| Device ID | K871674 |
| 510k Number | K871674 |
| Device Name: | TICARCILLIN/CLVULINIC ACID 85 MCG SUSCEPTIBILITY D |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | ORGANON TEKNIKA CORP. 5516 NICHOLSON LN. Kensington, TX 20895 |
| Contact | Robert Wurzel |
| Correspondent | Robert Wurzel ORGANON TEKNIKA CORP. 5516 NICHOLSON LN. Kensington, TX 20895 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-29 |
| Decision Date | 1987-05-15 |