Blood Storage Refrigerators And Freezers

Refrigerator, Freezer, Blood Storage

Connaught Laboratories Limited

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

Pre-market Notification Details

Device IDBK920006
510k NumberBK920006
Device Name:Blood Storage Refrigerators And Freezers
ClassificationRefrigerator, Freezer, Blood Storage
Applicant Connaught Laboratories Limited discovery Drive Swiftwater,  PA  18370
Product CodeKSE  
CFR Regulation Number864.9700 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-02
Decision Date1992-07-17

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