Sequential Culture Media (Fertilization Medium [without HSA/rHA, With HSA, With RHA], Cleavage Medium [without HSA/rHA, With HSA, With RHA], Blastocyst Medium [without HSA/rHA, With HSA, With RHA])

Media, Reproductive

Kitazato Corporation

The following data is part of a premarket notification filed by Kitazato Corporation with the FDA for Sequential Culture Media (fertilization Medium [without Hsa/rha, With Hsa, With Rha], Cleavage Medium [without Hsa/rha, With Hsa, With Rha], Blastocyst Medium [without Hsa/rha, With Hsa, With Rha]).

Pre-market Notification Details

Device IDK200249
510k NumberK200249
Device Name:Sequential Culture Media (Fertilization Medium [without HSA/rHA, With HSA, With RHA], Cleavage Medium [without HSA/rHA, With HSA, With RHA], Blastocyst Medium [without HSA/rHA, With HSA, With RHA])
ClassificationMedia, Reproductive
Applicant Kitazato Corporation 81 Nakajima Fuji-shi,  JP 416-0907
ContactFutoshi Inoue
CorrespondentAudrey Swearingen
Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin,  TX  78746
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-03
Decision Date2020-10-23

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