The following data is part of a premarket notification filed by Asahi Kasei Pharma Corporation with the FDA for Lucica Glycated Albumin-l.
| Device ID | K170147 |
| 510k Number | K170147 |
| Device Name: | Lucica Glycated Albumin-L |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | ASAHI KASEI PHARMA CORPORATION 1-105 KANDA JINBOCHO CHIYODA-KU Tokyo, JP 101-8101 |
| Contact | Hideji Hiraoka |
| Correspondent | Chris Sloan QUINTILESIMS 1801 ROCKVILLE PIKE SUITE 300 Rockville, MD 20852 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-17 |
| Decision Date | 2017-10-12 |
| Summary: | summary |