The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Ammonia Reagent.
| Device ID | K003196 |
| 510k Number | K003196 |
| Device Name: | SYNCHRON SYSTEMS AMMONIA REAGENT |
| Classification | Enzymatic Method, Ammonia |
| Applicant | BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Contact | Lucinda Stockert |
| Correspondent | Lucinda Stockert BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Product Code | JIF |
| CFR Regulation Number | 862.1065 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-12 |
| Decision Date | 2000-12-22 |