FDA 510(k) Applications for Medical Device Product Code "JCM"
(Control, Hemoglobin, Abnormal)

FDA 510(k) Number Applicant Device Name Decision Date
K053031 CANTEBURY SCIENTIFIC LTD. EXTENDSURE HBFASC CONTROL 12/07/2005
K011389 CANTERBURY HEALTH LABORATORIES HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) 06/21/2001
K983704 ROCHE DIAGNOSTIC SYSTEMS, INC. MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE 02/10/1999


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