
Biosafe Laboratories, Inc.
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ANEMIAPRO SELF-SCREENER is an FDA 510(k)-cleared medical device (K042379) manufactured by Biosafe Laboratories, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 14, 2004. Regulation: 8.