The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Ra 80 Eiken.
Device ID | K854820 |
510k Number | K854820 |
Device Name: | RA 80 EIKEN |
Classification | System, Test, Rheumatoid Factor |
Applicant | SYN-KIT, INC. 9231 ETON AVE. Chatsworth, CA 91311 |
Contact | James F Godfrey |
Correspondent | James F Godfrey SYN-KIT, INC. 9231 ETON AVE. Chatsworth, CA 91311 |
Product Code | DHR |
CFR Regulation Number | 866.5775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-03 |
Decision Date | 1986-01-17 |