The following data is part of a premarket notification filed by Cone Bioproducts with the FDA for Hba1c Linearity Set.
Device ID | K052010 |
510k Number | K052010 |
Device Name: | HBA1C LINEARITY SET |
Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
Applicant | CONE BIOPRODUCTS 1008 N. RIVER ST. Seguin, TX 78155 |
Contact | William Cone |
Correspondent | William Cone CONE BIOPRODUCTS 1008 N. RIVER ST. Seguin, TX 78155 |
Product Code | JJX |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-25 |
Decision Date | 2005-10-04 |
Summary: | summary |