The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Fast Formalert.
| Device ID | K853555 |
| 510k Number | K853555 |
| Device Name: | FAST FORMALERT |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | ORGANON TEKNIKA CORP. 5300 SOUTH PORTLAND AVE. Oklahoma City, OK 73119 |
| Contact | Martin Roberts |
| Correspondent | Martin Roberts ORGANON TEKNIKA CORP. 5300 SOUTH PORTLAND AVE. Oklahoma City, OK 73119 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-26 |
| Decision Date | 1986-06-26 |