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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Spectral Medical, Inc.. It received FDA 510(k) clearance on 2019-03-12 under 510(k) 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. The listed applicant is Spectral Medical, Inc.. The 510(k) number is K183176.

When did Endotoxin Activity Assay (EAA) receive FDA 510(k) clearance?

Endotoxin Activity Assay (EAA) received FDA 510(k) clearance on 2019-03-12, under 510(k) number K183176.

Who is the listed applicant for Endotoxin Activity Assay (EAA)?

The FDA 510(k) record lists Spectral Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endotoxin Activity Assay (EAA)?

The FDA product code for Endotoxin Activity Assay (EAA) is NGS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07661303Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety EvaluationNOT_YET_RECRUITINGNCT07788144EAA-Guided AN69-oXiris and PMX-HP Therapy in Septic PatientsENROLLING_BY_INVITATION

Other records listing Spectral Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170790SAM CRRT Unit, SAM Cassette CRRT

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.

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