Tosoh Medics, Inc. - FDA 510(k) Cleared Devices
41
Total
41
Cleared
0
Denied
FDA 510(k) Regulatory Record - Tosoh Medics, Inc. Chemistry ✕
24 devices
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
Cleared
Nov 09, 1993
AIA-PACK E2 ASSAY
Chemistry
193d
Cleared
Oct 22, 1993
AIA-PACK(R) PROG ASSAY
Chemistry
108d
Cleared
Sep 21, 1993
AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TES
Chemistry
139d
Cleared
Mar 04, 1993
AIA-PACK AFP CALIBRATION VERIFICATION TEST SET
Chemistry
157d
Cleared
Jan 11, 1993
ASIA-PACK TSH CALIBRATION VERIFICATION TEST SET
Chemistry
105d
Cleared
Jan 11, 1993
AIA-PACK PRL CALIBRATION VERIFICATION TEST SET
Chemistry
105d
Cleared
Dec 28, 1992
AIA-PACK BHCG CALIBRATION VERIFICATION TEST SET
Chemistry
91d
Cleared
Dec 28, 1992
AIA-PACK HCG CALIBRATION VERIFICATION TEST SET
Chemistry
91d
Cleared
Nov 16, 1992
AIA-PACK PAP CALIBRATION VERIFICATION TEST SET
Chemistry
49d
Cleared
Nov 16, 1992
AIA-PACK T-U CALIBRATION VERIFICATION TEST SET
Chemistry
49d
Cleared
Nov 16, 1992
AIA-PACK FSH CALIBRATION VERIFICATION TEST SET
Chemistry
49d
Cleared
Jan 25, 1991
AIA-PACK HGH
Chemistry
29d