KINGS BAY PRELUDE ONE STEP HCG COMBO KIT

KINGS BAY PRELUDE ONE STEP HCG COMBO KIT is an FDA 510(k)-cleared medical device (K931698) manufactured by King'S Bay Intl., Inc.. 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 November 4, 1993. Regulation: 8.