LORACARBEF GRAM-NAGATIVE PANELS

LORACARBEF GRAM-NAGATIVE PANELS is an FDA 510(k)-cleared medical device (K940917) manufactured by Baxter Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 7, 1995. Regulation: 8.