510(k) K243462

Diazyme Colorimetric Lithium Assay by Diazyme Laboratories, Inc. — Product Code NDW

K243462 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories, Inc. for the device "Diazyme Colorimetric Lithium Assay". The FDA issued a decision of Substantially Equivalent on August 1, 2025. The device falls under product code NDW (Assay, Porphyrin, Spectrophotometry, Lithium), a Class II device regulated under 21 CFR 862.3560. Diazyme Laboratories, Inc. has at least 10 other 510(k) clearances on record.