The following data is part of a premarket notification filed by Thermogenesis with the FDA for Blood Storage Refrigerators And Freezers.
Device ID | BK960072 |
510k Number | BK960072 |
Device Name: | Blood Storage Refrigerators And Freezers |
Classification | Refrigerator, Freezer, Blood Storage |
Applicant | Thermogenesis 3146 Gold Camp Drive suite 206 Rancho Cordova, CA 95670 |
Product Code | KSE |
CFR Regulation Number | 864.9700 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-13 |
Decision Date | 1999-02-12 |