SAS SPICER-EDWARDS 1 ANTISERUM

SAS SPICER-EDWARDS 1 ANTISERUM is an FDA 510(k)-cleared medical device (K955223) manufactured by Sa Scientific, 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 12, 1996. Regulation: 8.