510(k) K801889

MODEL 203S CLINICAL CHEMISTRY ANALYZER by Gilford Instrument Laboratories, Inc. — Product Code JJE

K801889 is an FDA 510(k) premarket notification submitted by Gilford Instrument Laboratories, Inc. for the device "MODEL 203S CLINICAL CHEMISTRY ANALYZER". The FDA issued a decision of Substantially Equivalent on September 26, 1980. The device falls under product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use), a Class I device regulated under 21 CFR 862.2160. Gilford Instrument Laboratories, Inc. has at least 10 other 510(k) clearances on record.