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Tosoh Medics, Inc.

FDA 510(k) & PMA Approved Devices — 41 products

Total Devices41
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K023893 ST AIA-PACK CEA ENZYME IMMUNOASSAYDHX2002-12-18 View
510(k) K023091 ST AIA-PACK TESTOSTERONE ASSAYCDZ2002-12-17 View
510(k) K023894 ST AIA-PACK AFP ENZYME IMMUNOASSAYLOJ2002-12-17 View
510(k) K023891 ST AIA-PACK CA 125 ENZYME IMMUNOASSAYLTK2002-12-06 View
510(k) K020489 G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODEJPD2002-05-14 View
510(k) K012820 AIA-PACK CTNI 2ND-GEN ASSAYMMI2001-12-14 View
510(k) K011434 G7 AUTOMATED HPLC ANALYZERLCP2001-09-18 View
510(k) K010796 AIA-PACK BRCA, ST AIA PACK BRCAMOI2001-08-16 View
510(k) K992365 AIA-PACK FOLATE ASSAYCGN1999-08-10 View
510(k) K990431 AIA-PACK CA 125LTK1999-06-03 View
510(k) K991252 AIA-PACK FT3 ASSAYCDP1999-05-11 View
510(k) K984359 AIA-PACK TROPONIN I ASSAYMMI1998-12-23 View
510(k) K981522 AIA-PACK TGAB ASSAYJZO1998-10-08 View
510(k) K981521 AIA-PACK TPOAB ASSAYJZO1998-10-08 View
510(k) K981012 AIA-PACK MYOGLOBIN ASSAYDDR1998-05-28 View
510(k) K972697 AIA-PACK IGE II ASSAYDGC1997-10-03 View
510(k) K972265 A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZERLCP1997-09-25 View
510(k) K972586 AIA-PACK TSH 3RD-GEN ASSAYJLW1997-08-29 View
510(k) K971103 AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEMKHO1997-06-27 View
510(k) K964348 AIA-PACK B12 ASSAYCDD1997-01-13 View
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