Endotoxin Activity Assay (EAA)— 510(k) K183176

Name: FDA 510(k) clearance K183176
Creator: U.S. Food and Drug Administration
Published: 2019-03-12

Substantially Equivalent

Spectral Medical, Inc.

FDA 510(k) clearance K183176 for Endotoxin Activity Assay (EAA), Substantially Equivalent on 2019-03-12. Applicant: Spectral Medical, Inc.. Device class: 2.

Clearance details

Applicant: Spectral Medical, Inc.
Product code: Code NGS
Device class: Class 2
Regulation: 21 CFR 866.3210
Advisory panel: Microbiology
Date received: 2018-11-16
Decision date: 2019-03-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

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