
Thermo Bioanalysis Corp.
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CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO is an FDA 510(k)-cleared medical device (K981795) manufactured by Thermo Bioanalysis 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 June 11, 1998. Regulation: 8.