The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Beckman Beta-2-microglobulin (b2m).
| Device ID | K940353 |
| 510k Number | K940353 |
| Device Name: | BECKMAN BETA-2-MICROGLOBULIN (B2M) |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Contact | Don W Hart |
| Correspondent | Don W Hart BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Product Code | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-25 |
| Decision Date | 1994-04-21 |