The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Immunochemistry System Beta-2-microglobulin Reagent.
| Device ID | K973813 |
| 510k Number | K973813 |
| Device Name: | IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Contact | Annette Hellie |
| Correspondent | Annette Hellie BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Product Code | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-07 |
| Decision Date | 1997-11-20 |
| Summary: | summary |