The following data is part of a premarket notification filed by Skyla Corporation H.s.p.b. with the FDA for Skyla Hi Hemoglobin A1c System (skyla Hi Analyzer And Skyla Hi Hemoglobin A 1 C Reagent Kit).
| Device ID | K173127 |
| 510k Number | K173127 |
| Device Name: | Skyla Hi Hemoglobin A1c System (skyla Hi Analyzer And Skyla Hi Hemoglobin A 1 C Reagent Kit) |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | Skyla Corporation H.S.P.B. 1f. No. 8, Dusing Rd., Hsinchu Science Park Hsinchu, TW 30078 |
| Contact | Cindy Lu |
| Correspondent | Feng-yu Lee IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-09-25 |
| Summary: | summary |