NEOLYNX SCREENING APPLICATION MANAGER— 510(k) K003584

Name: FDA 510(k) clearance K003584
Creator: U.S. Food and Drug Administration
Published: 2001-03-19

Substantially Equivalent

Micromass, Inc.

FDA 510(k) clearance K003584 for NEOLYNX SCREENING APPLICATION MANAGER, Substantially Equivalent on 2001-03-19. Applicant: Micromass, Inc.. Device class: 2.

Clearance details

Applicant: Micromass, Inc.
Product code: Code JNB
Device class: Class 2
Regulation: 21 CFR 862.1555
Advisory panel: Clinical Chemistry
Date received: 2000-11-20
Decision date: 2001-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milford, MA, US

Download summary PDF View on FDA.gov ↗

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