The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Beckman Alpha-1-microglobulin (a1m) Reagent.
| Device ID | K933078 |
| 510k Number | K933078 |
| Device Name: | BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT |
| Classification | Alpha-1 Microglobulin, Antigen, Antiserum, Control |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Contact | William Ryan |
| Correspondent | William Ryan BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Product Code | MGA |
| CFR Regulation Number | 866.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-23 |
| Decision Date | 1994-01-11 |