
Amersham Corp.
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OB-GYN CONTROL SERA (CODE 196300) is an FDA 510(k)-cleared medical device (K761309) manufactured by Amersham Corp.. 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 29, 1976. Regulation: 8.