The following data is part of a premarket notification filed by Cone Bioproducts with the FDA for Cone-trol Hemoglobin A1c Control Set.
| Device ID | K121534 |
| 510k Number | K121534 |
| Device Name: | CONE-TROL HEMOGLOBIN A1C CONTROL SET |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | CONE BIOPRODUCTS 1012 N. AUSTIN ST. Seguin, TX 78155 |
| Contact | Gail Schievelbein |
| Correspondent | Gail Schievelbein CONE BIOPRODUCTS 1012 N. AUSTIN 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 | 2012-05-24 |
| Decision Date | 2012-06-20 |
| Summary: | summary |