
Technicon Instruments Corp.
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CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE) is an FDA 510(k)-cleared medical device (K901229) manufactured by Technicon Instruments 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 May 3, 1990. Regulation: 8.