Tosoh Medics, Inc. - FDA 510(k) Cleared Devices
41
Total
41
Cleared
0
Denied
FDA 510(k) Regulatory Record - Tosoh Medics, Inc. Immunology ✕
13 devices
Cleared
Dec 18, 2002
ST AIA-PACK CEA ENZYME IMMUNOASSAY
Immunology
26d
Cleared
Dec 17, 2002
ST AIA-PACK AFP ENZYME IMMUNOASSAY
Immunology
25d
Cleared
Dec 06, 2002
ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
Immunology
14d
Cleared
Aug 16, 2001
AIA-PACK BRCA, ST AIA PACK BRCA
Immunology
153d
Cleared
Jun 03, 1999
AIA-PACK CA 125
Immunology
112d
Cleared
Oct 08, 1998
AIA-PACK TPOAB ASSAY
Immunology
163d
Cleared
Oct 08, 1998
AIA-PACK TGAB ASSAY
Immunology
163d
Cleared
May 28, 1998
AIA-PACK MYOGLOBIN ASSAY
Immunology
71d
Cleared
Oct 03, 1997
AIA-PACK IGE II ASSAY
Immunology
77d
Cleared
May 14, 1993
AIA-PACK IGE CALIBRATION VERIFICATION TEST SET
Immunology
228d
Cleared
Mar 18, 1993
AIA-PACK CEA CALIBRATION VERIFICATION TEST SET
Immunology
171d
Cleared
Dec 15, 1992
AIA-PACK FER CALIBRATION VERIFICATION TEST SET
Immunology
78d