CryoRobot Select System

Automated Cryopreservation Storage System

TMRW Life Sciences, Inc.

The following data is part of a premarket notification filed by Tmrw Life Sciences, Inc. with the FDA for Cryorobot Select System.

Pre-market Notification Details

Device IDK221086
510k NumberK221086
Device Name:CryoRobot Select System
ClassificationAutomated Cryopreservation Storage System
Applicant TMRW Life Sciences, Inc. 250 Hudson Street Floor 6 New York,  NY  10013
ContactChristina Miracle
CorrespondentChristina Miracle
TMRW Life Sciences, Inc. 250 Hudson Street Floor 6 New York,  NY  10013
Product CodeQUJ  
CFR Regulation Number884.6120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-13
Decision Date2022-11-04

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