AESKULSKA BETA2-GLYCO-A

System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)

AESKU, INC

The following data is part of a premarket notification filed by Aesku, Inc with the FDA for Aeskulska Beta2-glyco-a.

Pre-market Notification Details

Device IDK062217
510k NumberK062217
Device Name:AESKULSKA BETA2-GLYCO-A
ClassificationSystem,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
Applicant AESKU, INC 8880 NORTHWEST 18TH TERRACE Miami,  FL  33172
ContactDavid Bell
CorrespondentDavid Bell
AESKU, INC 8880 NORTHWEST 18TH TERRACE Miami,  FL  33172
Product CodeMSV  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-01
Decision Date2006-12-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04250289503099 K062217 000
04250289500852 K062217 000
04250289500869 K062217 000
04250289500951 K062217 000
04250289502825 K062217 000
04250289502832 K062217 000
04250289502849 K062217 000
04250289503075 K062217 000
04250289503082 K062217 000
B24235B2SHUE010 K062217 000

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