The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Unicel Dxc Synchron Systems Hemoglobin A1c3 (hba1c3) Reagent.
| Device ID | K140829 |
| 510k Number | K140829 |
| Device Name: | UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | BECKMAN COULTER, INC. 250 S. KRAEMER BLVD. MAIL STOP E1.SE.01 Brea, CA 92821 |
| Contact | Annette Hellie |
| Correspondent | Annette Hellie BECKMAN COULTER, INC. 250 S. KRAEMER BLVD. MAIL STOP E1.SE.01 Brea, CA 92821 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-01 |
| Decision Date | 2014-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590191702 | K140829 | 000 |