
Caltag Laboratories, Inc.
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CALTAG FETAL HEMOGLOBIN TEST is an FDA 510(k)-cleared medical device (K990641) 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 September 16, 1999. Regulation: 8.