Endotoxin Activity Assay (EAA)
K-Number: K183176 · 2019-03-12
ApplicantSpectral Medical, Inc.
Decision Date2019-03-12
Product CodeNGS
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Endotoxin Activity Assay (EAA) is a medical device manufactured by Spectral Medical, Inc.. It received FDA 510(k) clearance on 2019-03-12 under approval number K183176. The device is classified under product code NGS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Endotoxin Activity Assay (EAA)?
Endotoxin Activity Assay (EAA) is a medical device that received FDA 510(k) clearance on 2019-03-12. It is manufactured by Spectral Medical, Inc.. The 510(k) number is K183176.
When was Endotoxin Activity Assay (EAA) approved by the FDA?
Endotoxin Activity Assay (EAA) received FDA 510(k) clearance on 2019-03-12, under approval number K183176.
What company makes Endotoxin Activity Assay (EAA)?
Endotoxin Activity Assay (EAA) is manufactured by Spectral Medical, Inc..
What is the FDA product code for Endotoxin Activity Assay (EAA)?
The FDA product code for Endotoxin Activity Assay (EAA) is NGS.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.