
Roche Diagnostics Corp.
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MODIFICATION TO ELECSYS FSH II CALSET is an FDA 510(k)-cleared medical device (K012399) manufactured by Roche Diagnostics Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 23, 2001. Regulation: 8.