The following data is part of a premarket notification filed by Eiken Chemical Co., Inc. with the FDA for Multipurpose Immunochemistry System La-2000 Latex.
| Device ID | K864342 |
| 510k Number | K864342 |
| Device Name: | MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX |
| Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Applicant | EIKEN CHEMICAL CO., INC. 2004 WALNUT AVE. Venice, CA 90291 |
| Contact | James Godfrey |
| Correspondent | James Godfrey EIKEN CHEMICAL CO., INC. 2004 WALNUT AVE. Venice, CA 90291 |
| Product Code | CFN |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-04 |
| Decision Date | 1986-12-01 |