PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II

PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II is an FDA 510(k)-cleared medical device (K903913) manufactured by Baxter Healthcare Corp. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 26, 1990. Regulation: 8.