510(k) K892380

DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III by Baxter Healthcare Corp — Product Code DIF

K892380 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III". The FDA issued a decision of Substantially Equivalent on Feb 8, 1990. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Baxter Healthcare Corp has 507 other 510(k) clearances on record.