
In-Line Diagnostics Corp.
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CRIT-LINE BLOOD CHAMBER WITH E-BEAM is an FDA 510(k)-cleared medical device (K935958) manufactured by In-Line Diagnostics Corp.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 18, 1995. Regulation: 8.