
Diagnostic Products Corp.
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SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) is an FDA 510(k)-cleared medical device (K902575) manufactured by Diagnostic Products 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 October 3, 1990. Regulation: 8.