
Bhp Diagnostix, Inc.
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SERACON(TM) CAL (PRODUCT NO. DO35) is an FDA 510(k)-cleared medical device (K862594) manufactured by Bhp Diagnostix, 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 August 18, 1986. Regulation: 8.