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 |