The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Unicel Dxc Synchron Systems Hemoglobin Alc-(hba1c-) Reagent.
| Device ID | K121492 |
| 510k Number | K121492 |
| Device Name: | UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD A2.SW.09 Brea, CA 92822 |
| Contact | Annette Hellie |
| Correspondent | Annette Hellie BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD A2.SW.09 Brea, CA 92822 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-21 |
| Decision Date | 2012-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590207366 | K121492 | 000 |