
Dade Behring, Inc.
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STRATUS CS MYO CALPAK is an FDA 510(k)-cleared medical device (K981101) manufactured by Dade Behring, Inc.. 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 April 14, 1998. Regulation: 8.