RSV ANTIGEN TEST— 510(k) K942173

Substantially Equivalent

Neogenex

FDA 510(k) clearance K942173 for RSV ANTIGEN TEST, Substantially Equivalent on 1994-06-30. Applicant: Neogenex. Device class: 1.

Clearance details

Applicant: Neogenex
Product code: Code LKT
Device class: Class 1
Regulation: 21 CFR 866.3480
Advisory panel: Microbiology
Date received: 1994-05-05
Decision date: 1994-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Everett, WA, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.