510(k) K973609

IDA-4 AND IPT-MC by Bio-Tek Instruments, Inc. — Product Code FRN

K973609 is an FDA 510(k) premarket notification submitted by Bio-Tek Instruments, Inc. for the device "IDA-4 AND IPT-MC". The FDA issued a decision of ST on December 18, 1997. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Bio-Tek Instruments, Inc. has at least 10 other 510(k) clearances on record.