ALERE PBP2A SA/CONS CULTURE COLONY TEST

ALERE PBP2A SA/CONS CULTURE COLONY TEST is an FDA 510(k)-cleared medical device (K133851) manufactured by Alere Scarborough, 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 September 2, 2014. Regulation: 8.