510(k) K003583

LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 by Trace America, Inc. — Product Code NDW

K003583 is an FDA 510(k) premarket notification submitted by Trace America, Inc. for the device "LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901". The FDA issued a decision of Substantially Equivalent on January 17, 2001. The device falls under product code NDW (Assay, Porphyrin, Spectrophotometry, Lithium), a Class II device regulated under 21 CFR 862.3560. Trace America, Inc. has at least 10 other 510(k) clearances on record.