510(k) K994045

PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 by Primus Corp. — Product Code LCP

K994045 is an FDA 510(k) premarket notification submitted by Primus Corp. for the device "PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2". The FDA issued a decision of Substantially Equivalent on December 21, 1999. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Primus Corp. has at least 10 other 510(k) clearances on record.