ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE— 510(k) DEN030002

Name: FDA 510(k) clearance DEN030002
Creator: U.S. Food and Drug Administration
Published: 2003-06-16

Unknown

Spectral Diagnostics, Inc.

FDA 510(k) clearance DEN030002 for ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE, Unknown on 2003-06-16. Applicant: Spectral Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Spectral Diagnostics, Inc.
Product code: Code NGS
Device class: Class 2
Regulation: 21 CFR 866.3210
Advisory panel: Microbiology
Date received: 2003-04-14
Decision date: 2003-06-16
Decision: Unknown
Clearance type: Post-NSE
Location: Rockville, MD, US

View on FDA.gov ↗

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