
Biosafe Laboratories, Inc.
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SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM is an FDA 510(k)-cleared medical device (K012221) manufactured by Biosafe Laboratories, 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 2, 2002. Regulation: 8.