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Tosoh Medics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
41
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K023893ST AIA-PACK CEA ENZYME IMMUNOASSAYDecember 18, 2002
K023091ST AIA-PACK TESTOSTERONE ASSAYDecember 17, 2002
K023894ST AIA-PACK AFP ENZYME IMMUNOASSAYDecember 17, 2002
K023891ST AIA-PACK CA 125 ENZYME IMMUNOASSAYDecember 6, 2002
K020489G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODEMay 14, 2002
K012820AIA-PACK CTNI 2ND-GEN ASSAYDecember 14, 2001
K011434G7 AUTOMATED HPLC ANALYZERSeptember 18, 2001
K010796AIA-PACK BRCA, ST AIA PACK BRCAAugust 16, 2001
K992365AIA-PACK FOLATE ASSAYAugust 10, 1999
K990431AIA-PACK CA 125June 3, 1999
K991252AIA-PACK FT3 ASSAYMay 11, 1999
K984359AIA-PACK TROPONIN I ASSAYDecember 23, 1998
K981521AIA-PACK TPOAB ASSAYOctober 8, 1998
K981522AIA-PACK TGAB ASSAYOctober 8, 1998
K981012AIA-PACK MYOGLOBIN ASSAYMay 28, 1998
K972697AIA-PACK IGE II ASSAYOctober 3, 1997
K972265A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZERSeptember 25, 1997
K972586AIA-PACK TSH 3RD-GEN ASSAYAugust 29, 1997
K971103AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEMJune 27, 1997
K964348AIA-PACK B12 ASSAYJanuary 13, 1997