ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE

ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE is an FDA 510(k)-cleared medical device (K853049) manufactured by Simmler, 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 August 1, 1985. Regulation: 8.