The following data is part of a premarket notification filed by Serex, Inc. with the FDA for Beta-2 Microglobulin Eia.
| Device ID | K901333 |
| 510k Number | K901333 |
| Device Name: | BETA-2 MICROGLOBULIN EIA |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| Applicant | SEREX, INC. 38 FRANKLIN ST. Tenafly, NJ 07670 |
| Contact | Charles B Breuer |
| Correspondent | Charles B Breuer SEREX, INC. 38 FRANKLIN ST. Tenafly, NJ 07670 |
| Product Code | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-20 |
| Decision Date | 1990-04-02 |