
Caltag Laboratories, Inc.
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CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION is an FDA 510(k)-cleared medical device (K951073) manufactured by Caltag 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 20, 1995. Regulation: 8.