
Bionike Laboratories, Inc.
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BIONIKE A/Q PREGNANCY TEST is an FDA 510(k)-cleared medical device (K960992) manufactured by Bionike 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 April 24, 1996. Regulation: 8.