
Roche Image Analysis Systems
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IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM is an FDA 510(k)-cleared medical device (K952490) manufactured by Roche Image Analysis Systems. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 14, 1995. Regulation: 8.