The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Cpr Slide Eiken.
| Device ID | K854819 |
| 510k Number | K854819 |
| Device Name: | CPR SLIDE EIKEN |
| Classification | System, Test, C-reactive Protein |
| 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 | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-03 |
| Decision Date | 1986-02-26 |