
Caltag Laboratories, Inc.
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CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY is an FDA 510(k)-cleared medical device (K963954) 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 November 24, 1996. Regulation: 8.