
A.P. Total Care, Inc.
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BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 is an FDA 510(k)-cleared medical device (K991866) manufactured by A.P. Total Care, 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 1, 1999. Regulation: 8.