IDI-MRSA ASSAY— 510(k) K042357

Name: FDA 510(k) clearance K042357
Creator: U.S. Food and Drug Administration
Published: 2004-10-22

Substantially Equivalent

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

FDA 510(k) clearance K042357 for IDI-MRSA ASSAY, Substantially Equivalent on 2004-10-22. 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: 2004-08-31
Decision date: 2004-10-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Hydes, MD, US

Download summary PDF View on FDA.gov ↗

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