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

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..

Clearance details

Applicant: Spectral Medical, Inc.
Product code: Code NGS
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 ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.