IMMUNOWELL LYME (P39 RECOMBINANT) TEST

IMMUNOWELL LYME (P39 RECOMBINANT) TEST is an FDA 510(k)-cleared medical device (K911599) manufactured by General Biometrics, 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 December 29, 1991. Regulation: 8.