MODELS IDA-2 PLUS AND IPT-1

MODELS IDA-2 PLUS AND IPT-1 is an FDA 510(k)-cleared medical device (K961862) manufactured by Bio-Tek Instruments, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 25, 1997. Regulation: 8.