The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Trep Card Eiken.
| Device ID | K820567 |
| 510k Number | K820567 |
| Device Name: | TREP CARD EIKEN |
| Classification | Antigens, Nontreponemal, All |
| Applicant | SYN-KIT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GMQ |
| CFR Regulation Number | 866.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-02 |
| Decision Date | 1982-04-14 |