The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Unicel Dxc Synchron Systems Glucose Reagent (gluh).
| Device ID | K131189 |
| 510k Number | K131189 |
| Device Name: | UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) |
| Classification | Hexokinase, Glucose |
| Applicant | BECKMAN COULTER, INC. 250 S. KRAEMER ST Brea, CA 92821 |
| Contact | Yvette Lloyd |
| Correspondent | Yvette Lloyd BECKMAN COULTER, INC. 250 S. KRAEMER ST Brea, CA 92821 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-26 |
| Decision Date | 2014-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590193072 | K131189 | 000 |