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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Endotoxin Activity, Chemiluminescent
510(k) Number K183176
Device Name Endotoxin Activity Assay (EAA)
Applicant
Spectral Medical, Inc.
135 The W. Mall, Unit 2
Toronto,  CA M9C1C2
Applicant Contact Danijela Domljanovic
Correspondent
Spectral Medical, Inc.
135 The W. Mall, Unit 2
Toronto,  CA M9C1C2
Correspondent Contact Danijela Domljanovic
Regulation Number866.3210
Classification Product Code
NGS  
Date Received11/16/2018
Decision Date 03/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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