HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY

HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY is an FDA 510(k)-cleared medical device (K862083) manufactured by Hygeia Sciences. 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 July 1, 1986. Regulation: 8.