FDA 510(k) K880038, FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527, by Sigma Diagnostics, Inc.

510(K) Number: K880038
Device Name: FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527
Manufacturer: Sigma Diagnostics, Inc.
Device Classification Name: whole blood hemoglobin determination
Regulation Number: 864.7500
Classification Product Code: KHG
Date Received: 01/05/1988
Decision Date: 04/21/1988
Regulation Medical Specialty: Hematology