IDI-STREP B ASSAY— 510(k) K022504

Substantially Equivalent

Infectio Diagnostic, Inc.

FDA 510(k) clearance K022504 for IDI-STREP B ASSAY, Substantially Equivalent on 2002-11-18. Applicant: Infectio Diagnostic, Inc.. Device class: 1.

Clearance details

Applicant: Infectio Diagnostic, Inc.
Product code: Code NJR
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 2002-07-29
Decision date: 2002-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baldwin, MD, US

Download summary PDF View on FDA.gov ↗

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