
Ameritek, Inc.
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DBEST ONE-STEP HCG SERUM/URINE TEST is an FDA 510(k)-cleared medical device (K973957) manufactured by Ameritek, 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 December 16, 1997. Regulation: 8.