The following data is part of a premarket notification filed by Infopia Co., Ltd with the FDA for Hemocue Hba1c 501 Glycosylated Hemoglobin Monitoring System.
| Device ID | K141750 |
| 510k Number | K141750 |
| Device Name: | HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | INFOPIA CO., LTD 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92833 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung INFOPIA CO., LTD 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92833 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-30 |
| Decision Date | 2014-07-24 |
| Summary: | summary |