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

FDA 510(k) Number Applicant Device Name Decision Date
K911347 BIO-RAD LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL 06/10/1991
K053031 CANTEBURY SCIENTIFIC LTD. EXTENDSURE HBFASC CONTROL 12/07/2005
K011389 CANTERBURY HEALTH LABORATORIES HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) 06/21/2001
K913427 CREATIVE LABORATORY PRODUCTS, INC. SICKLE HEMOGLOBIN (HBA/S) CONTROL SET 11/19/1991
K820037 DIAGNOSTIC TECHNOLOGY, INC. SICKLE-CHECK 02/04/1982
K933086 HELENA LABORATORIES AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 10/31/1994
K820787 HELENA LABORATORIES HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL 04/08/1982
K910431 ISOLAB, INC. HEMOCARD CONTROL 03/11/1991
K931234 ISOLAB, INC. HEMOCARD CONTROL HB-AA, AE, FAA, FAE 05/11/1993
K924173 ISOLAB, INC. HEMOCARD(TM) CONTROL 12/01/1992
K942222 ISOLAB, INC. QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS 01/20/1995
K983704 ROCHE DIAGNOSTIC SYSTEMS, INC. MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE 02/10/1999


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