510(k) K903913

PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II by Baxter Healthcare Corp — Product Code JIX

K903913 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II". The FDA issued a decision of Substantially Equivalent on Sep 27, 1990. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Baxter Healthcare Corp has 507 other 510(k) clearances on record.