The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Creatinine Reagent.
| Device ID | K071283 |
| 510k Number | K071283 |
| Device Name: | SYNCHRON SYSTEMS CREATININE REAGENT |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. M/S W-110 Brea, CA 92822 -8000 |
| Contact | Tara M Viviani |
| Correspondent | Tara M Viviani BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. M/S W-110 Brea, CA 92822 -8000 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-07 |
| Decision Date | 2007-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590203344 | K071283 | 000 |