510(k) K992921

PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II by Primus Corp. — Product Code LCP

K992921 is an FDA 510(k) premarket notification submitted by Primus Corp. for the device "PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II". The FDA issued a decision of Substantially Equivalent on November 12, 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.