510(k) K051012

PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML. by Salimetrics, LLC — Product Code JIT

K051012 is an FDA 510(k) premarket notification submitted by Salimetrics, LLC for the device "PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML.". The FDA issued a decision of Substantially Equivalent on July 19, 2005. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Salimetrics, LLC has at least 2 other 510(k) clearances on record.