The following data is part of a premarket notification filed by Sentinel Ch. Spa with the FDA for Sentinel Plasmaproteins Cal 3x.
Device ID | K081533 |
510k Number | K081533 |
Device Name: | SENTINEL PLASMAPROTEINS CAL 3X |
Classification | Calibrator, Multi-analyte Mixture |
Applicant | SENTINEL CH. SpA Via Robert Koch, 2 Milano, IT 20152 |
Contact | Fabio Rota |
Correspondent | Fabio Rota SENTINEL CH. SpA Via Robert Koch, 2 Milano, IT 20152 |
Product Code | JIX |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-06-02 |
Decision Date | 2008-06-25 |
Summary: | summary |