
Baxter Diagnostics, Inc.
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DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI is an FDA 510(k)-cleared medical device (K933188) manufactured by Baxter Diagnostics, 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 21, 1993. Regulation: 8.