PACE-4-AUTOMATIC RIA GAMMA-COUTER

PACE-4-AUTOMATIC RIA GAMMA-COUTER is an FDA 510(k)-cleared medical device (K802578) manufactured by Philips Medical Systems (Cleveland), Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 17, 1980. Regulation: 8.