Blood Storage Refrigerators And Freezers

Refrigerator, Freezer, Blood Storage

Thermogenesis

The following data is part of a premarket notification filed by Thermogenesis with the FDA for Blood Storage Refrigerators And Freezers.

Pre-market Notification Details

Device IDBK960072
510k NumberBK960072
Device Name:Blood Storage Refrigerators And Freezers
ClassificationRefrigerator, Freezer, Blood Storage
Applicant Thermogenesis 3146 Gold Camp Drive suite 206 Rancho Cordova,  CA  95670
Product CodeKSE  
CFR Regulation Number864.9700 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-13
Decision Date1999-02-12

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