510(k) K022725

CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 by Good Biotech Corp. — Product Code JJX

K022725 is an FDA 510(k) premarket notification submitted by Good Biotech Corp. for the device "CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013". The FDA issued a decision of Substantially Equivalent on September 23, 2002. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Good Biotech Corp. has at least 7 other 510(k) clearances on record.