
ACON Laboratories, Inc.
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ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE is an FDA 510(k)-cleared medical device (K041946) manufactured by ACON Laboratories, 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 August 15, 2004. Regulation: 8.