The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Array(r) 360.
| Device ID | K922273 |
| 510k Number | K922273 |
| Device Name: | ARRAY(R) 360 |
| Classification | Nephelometer, For Clinical Use |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Contact | William T Ryan |
| Correspondent | William T Ryan BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Product Code | JQX |
| CFR Regulation Number | 862.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-14 |
| Decision Date | 1992-08-19 |