IDI-MRSA— 510(k) K033415

Substantially Equivalent

Infectio Diagnostic (I.D.I.), Inc.

FDA 510(k) clearance K033415 for IDI-MRSA, Substantially Equivalent on 2004-03-18. Applicant: Infectio Diagnostic (I.D.I.), Inc.. Device class: 2.

Clearance details

Applicant: Infectio Diagnostic (I.D.I.), Inc.
Product code: Code NQX
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2003-10-27
Decision date: 2004-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sainte-Foy, CA

Download summary PDF View on FDA.gov ↗

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