QUIKPAC II, ONE STEP HCG COMBO KIT

QUIKPAC II, ONE STEP HCG COMBO KIT is an FDA 510(k)-cleared medical device (K945951) manufactured by Syntron Bioresearch, 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 February 7, 1995. Regulation: 8.