SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT

SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT is an FDA 510(k)-cleared medical device (K970905) manufactured by Beckman Instruments, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 3, 1997. Regulation: 8.