510(k) K012367

VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D by Nichols Institute Diagnostics — Product Code JIT

K012367 is an FDA 510(k) premarket notification submitted by Nichols Institute Diagnostics for the device "VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D". The FDA issued a decision of Substantially Equivalent on October 9, 2001. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Nichols Institute Diagnostics has at least 10 other 510(k) clearances on record.