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 |