510(k) K903933

DADE(R) CSF.L, LIQ CEREBROSPIN FLUID CTRL LEV 1&2 by Baxter Healthcare Corp — Product Code JJY

K903933 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "DADE(R) CSF.L, LIQ CEREBROSPIN FLUID CTRL LEV 1&2". The FDA issued a decision of Substantially Equivalent on Oct 4, 1990. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Baxter Healthcare Corp has 507 other 510(k) clearances on record.