The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Immage Immunochemistry System Albumin (alb) Reagent.
| Device ID | K964695 |
| 510k Number | K964695 |
| Device Name: | IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT |
| Classification | Albumin, Antigen, Antiserum, Control |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Contact | Frank Marte |
| Correspondent | Frank Marte BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Product Code | DCF |
| CFR Regulation Number | 866.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-22 |
| Decision Date | 1997-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590223250 | K964695 | 000 |
| 15099590221201 | K964695 | 000 |