The following data is part of a premarket notification filed by Infopia Co., Ltd with the FDA for Hemocue Hba1c 501.
| Device ID | K121366 |
| 510k Number | K121366 |
| Device Name: | HEMOCUE HBA1C 501 |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | INFOPIA CO., LTD 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Maria F Griffin |
| Correspondent | Maria F Griffin INFOPIA CO., LTD 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-07 |
| Decision Date | 2012-09-07 |
| Summary: | summary |