510(k) K961862

MODELS IDA-2 PLUS AND IPT-1 by Bio-Tek Instruments, Inc. — Product Code FRN

K961862 is an FDA 510(k) premarket notification submitted by Bio-Tek Instruments, Inc. for the device "MODELS IDA-2 PLUS AND IPT-1". The FDA issued a decision of ST on February 26, 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.