The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Seroiden Strepto Kit 'eiken'.
Device ID | K861098 |
510k Number | K861098 |
Device Name: | SEROIDEN STREPTO KIT 'EIKEN' |
Classification | Antisera, All Groups, Streptococcus Spp. |
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 | GTZ |
CFR Regulation Number | 866.3740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-24 |
Decision Date | 1986-08-12 |