
Photec Diagnostics, Inc.
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APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 is an FDA 510(k)-cleared medical device (K853048) manufactured by Photec Diagnostics, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 27, 1985. Regulation: 8.