The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Beckman Immunoglobulin G (igg) Reagent, Urine Application, Urine Protein Calibrator, Control.
| Device ID | K951635 |
| 510k Number | K951635 |
| Device Name: | BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL |
| Classification | Igg, Antigen, Antiserum, Control |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Contact | Don W Hart |
| Correspondent | Don W Hart BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Product Code | DEW |
| Subsequent Product Code | CFN |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-07 |
| Decision Date | 1995-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590225384 | K951635 | 000 |
| 15099590224158 | K951635 | 000 |