510(k) K880038

FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527 by Sigma Diagnostics, Inc. — Product Code KHG

K880038 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527". The FDA issued a decision of Substantially Equivalent on April 21, 1988. The device falls under product code KHG (Whole Blood Hemoglobin Determination), a Class II device regulated under 21 CFR 864.7500. Sigma Diagnostics, Inc. has at least 10 other 510(k) clearances on record.