The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Immage Immunochemistry System.
| Device ID | K962294 |
| 510k Number | K962294 |
| Device Name: | IMMAGE IMMUNOCHEMISTRY SYSTEM |
| Classification | Nephelometer, For Clinical Use |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Contact | Sheri Hall |
| Correspondent | Sheri Hall BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Product Code | JQX |
| CFR Regulation Number | 862.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-14 |
| Decision Date | 1996-08-21 |
| Summary: | summary |