The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Aso Slide Eiken.
Device ID | K853276 |
510k Number | K853276 |
Device Name: | ASO SLIDE EIKEN |
Classification | Antistreptolysin - Titer/streptolysin O Reagent |
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 | GTQ |
CFR Regulation Number | 866.3720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-08-05 |
Decision Date | 1985-08-20 |