ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST

ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST is an FDA 510(k)-cleared medical device (K964461) manufactured by Teco Diagnostics. 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 February 10, 1997. Regulation: 8.