The following data is part of a premarket notification filed by Eiken Chemical Co., Inc. with the FDA for Multipurpose Immunochemistry Sys-la-2000.
| Device ID | K853391 |
| 510k Number | K853391 |
| Device Name: | MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000 |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | EIKEN CHEMICAL CO., INC. 2004 WALNUT AVE. Venice, CA 90291 |
| Contact | James F Godfrey |
| Correspondent | James F Godfrey EIKEN CHEMICAL CO., INC. 2004 WALNUT AVE. Venice, CA 90291 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-13 |
| Decision Date | 1985-10-01 |