The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Creatinine (crea) Reagent.
| Device ID | K060935 |
| 510k Number | K060935 |
| Device Name: | SYNCHRON SYSTEMS CREATININE (CREA) REAGENT |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Contact | Annette Hellie |
| Correspondent | Annette Hellie BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-05 |
| Decision Date | 2006-04-28 |
| Summary: | summary |