
Diagnostic Systems Laboratories, Inc.
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ACTIVE PSA IRMA (DSL-9700) is an FDA 510(k)-cleared medical device (K973244) manufactured by Diagnostic Systems Laboratories, 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 August 2, 1998. Regulation: 8.