The following data is part of a premarket notification filed by Cone Bioproducts with the FDA for Cone-trol Liquid Chemistry Controls.
Device ID | K121759 |
510k Number | K121759 |
Device Name: | CONE-TROL LIQUID CHEMISTRY CONTROLS |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | CONE BIOPRODUCTS 1012 N Austin St Seguin, TX 78155 |
Contact | Will Cone |
Correspondent | Will Cone CONE BIOPRODUCTS 1012 N Austin St Seguin, TX 78155 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-06-15 |
Decision Date | 2012-07-24 |
Summary: | summary |