
Boehringer Mannheim Corp.
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BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS is an FDA 510(k)-cleared medical device (K974825) manufactured by Boehringer Mannheim 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 January 29, 1998. Regulation: 8.