510(k) K831523

BETA SCAN NORMAL CONTROL SOLUTION by Orange Medical Instruments, Inc. — Product Code JJX

K831523 is an FDA 510(k) premarket notification submitted by Orange Medical Instruments, Inc. for the device "BETA SCAN NORMAL CONTROL SOLUTION". The FDA issued a decision of Substantially Equivalent on July 19, 1983. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Orange Medical Instruments, Inc. has at least 10 other 510(k) clearances on record.