The following data is part of a premarket notification filed by Beckman Coulter, Inc with the FDA for Glycosylated Hemoglobin Assay; Clinical Chemistry.
| Device ID | K120199 |
| 510k Number | K120199 |
| Device Name: | GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | BECKMAN COULTER, INC 250 S. KRAEMER BLVD MAIL STOP A2 SW. 08 Brea, CA 92821 |
| Contact | Beverly Harding |
| Correspondent | Beverly Harding BECKMAN COULTER, INC 250 S. KRAEMER BLVD MAIL STOP A2 SW. 08 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 | 2012-01-23 |
| Decision Date | 2012-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590012052 | K120199 | 000 |