The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Enzymatic Creatinine (cr-e) Reagent, Model A60298.
| Device ID | K091742 |
| 510k Number | K091742 |
| Device Name: | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 |
| Classification | Enzymatic Method, Creatinine |
| Applicant | BECKMAN COULTER, INC. 200 S. KRAEMER BLVD. M/S W-110 Brea, CA 92822 -8000 |
| Contact | Marine Boyajian |
| Correspondent | Marine Boyajian BECKMAN COULTER, INC. 200 S. KRAEMER BLVD. M/S W-110 Brea, CA 92822 -8000 |
| Product Code | JFY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-16 |
| Decision Date | 2009-08-14 |
| Summary: | summary |