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 |