
Qualisys Diagnostics, Inc.
Free shipping on orders over $99 · 30-day returns
FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM is an FDA 510(k)-cleared medical device (K994419) manufactured by Qualisys Diagnostics, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 27, 2000. Regulation: 8.