
Radiometer America, Inc.
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ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM is an FDA 510(k)-cleared medical device (K980130) manufactured by Radiometer America, 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 February 8, 1998. Regulation: 8.