The following data is part of a premarket notification filed by Arkray, Inc. with the FDA for Arkit Hba1c.
| Device ID | K030553 |
| 510k Number | K030553 |
| Device Name: | ARKIT HBA1C |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | ARKRAY, INC. 2320 SCIENTIFIC PARK DR. Wilmington, NC 28405 |
| Contact | Gary M Haight |
| Correspondent | Gary M Haight ARKRAY, INC. 2320 SCIENTIFIC PARK DR. Wilmington, NC 28405 |
| Product Code | LCP |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-21 |
| Decision Date | 2003-09-02 |
| Summary: | summary |