The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Image-immunochemistry System Urine Immunoglobulin.
| Device ID | K963974 |
| 510k Number | K963974 |
| Device Name: | IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN |
| Classification | Igg, Antigen, Antiserum, Control |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Contact | Annette Hellie |
| Correspondent | Annette Hellie BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Product Code | DEW |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-02 |
| Decision Date | 1997-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590226985 | K963974 | 000 |