Medical Device Manufacturer · US , Washington , DC

Tosoh Medics, Inc. - FDA 510(k) Cleared Devices

41 submissions · 41 cleared · Since 1990

41

Total

41

Cleared

0

Denied

FDA 510(k) Regulatory Record - Tosoh Medics, Inc. Chemistry ✕

24 devices

1-12 of 24

Cleared Dec 17, 2002

ST AIA-PACK TESTOSTERONE ASSAY

Chemistry · 91d

Cleared Dec 14, 2001

AIA-PACK CTNI 2ND-GEN ASSAY

Chemistry · 113d

Cleared Aug 10, 1999

AIA-PACK FOLATE ASSAY

Chemistry · 26d

Cleared May 11, 1999

AIA-PACK FT3 ASSAY

Chemistry · 28d

Cleared Dec 23, 1998

AIA-PACK TROPONIN I ASSAY

Chemistry · 16d

Cleared Aug 29, 1997

AIA-PACK TSH 3RD-GEN ASSAY

Chemistry · 49d

Cleared Jun 27, 1997

AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM

Chemistry · 93d

Cleared Jan 13, 1997

AIA-PACK B12 ASSAY

Chemistry · 74d

Cleared Nov 27, 1996

AIA-PACK FOLATE ASSAY

Chemistry · 27d

Cleared Nov 08, 1996

AIA-PACK FT3 ASSAY

Chemistry · 53d

Cleared Feb 13, 1996

AIA-PACK CPR ASSAY

Chemistry · 298d

Cleared Dec 15, 1995

AIA-PACK CORT ASSAY

Chemistry · 74d