IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM— 510(k) K952490

Name: FDA 510(k) clearance K952490
Creator: U.S. Food and Drug Administration
Published: 1995-12-15

Substantially Equivalent

Roche Image Analysis Systems

FDA 510(k) clearance K952490 for IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM, Substantially Equivalent on 1995-12-15. Applicant: Roche Image Analysis Systems. Device class: 2.

Clearance details

Applicant: Roche Image Analysis Systems
Product code: Code LJM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1995-05-30
Decision date: 1995-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elon College, NC, US

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