American Laboratory Products Co., Ltd. - FDA 510(k) Cleared Devices
27
Total
27
Cleared
0
Denied
FDA 510(k) Regulatory Record - American Laboratory Products Co., Ltd. Immunology ✕
22 devices
Cleared
Jan 29, 2002
CIC-C1Q EIA
Immunology
173d
Cleared
May 30, 2001
ALPCO MILENIA ANTI-TG EIA
Immunology
22d
Cleared
May 24, 2001
ALPCO MILENIA ANTI-TPO ELISA
Immunology
35d
Cleared
Feb 17, 1998
ORGENTEC ANTI-MPO (P-ANCA) ELISA
Immunology
71d
Cleared
Feb 17, 1998
ORGENTEC ANTI-PR3 (C-ANCA) ELISA
Immunology
71d
Cleared
Jul 14, 1997
THYROGLOBULIN ASSAY SYSTEM
Immunology
56d
Cleared
Nov 18, 1996
ORGENTEC ANTI-RNP/SM ELISA
Immunology
174d
Cleared
Nov 18, 1996
ORGENTEC ANTI-SM ELISA
Immunology
174d
Cleared
Nov 15, 1996
ORGENTEC ABTI-SS-BB(LA) ELISA
Immunology
171d
Cleared
Nov 15, 1996
ORGENTEC ANTI-JO-1 ELISA
Immunology
171d
Cleared
Nov 15, 1996
ORGENTEC ANTI-SS-A(RO) ELISA
Immunology
171d
Cleared
Nov 15, 1996
ORGENTEC ANTI-SCL 70 ELISA
Immunology
171d
Cleared
Oct 10, 1996
ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY
Immunology
73d
Cleared
Sep 09, 1996
ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY
Immunology
76d
Cleared
May 23, 1996
ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY
Immunology
176d
Cleared
Jul 18, 1995
ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY
Immunology
77d
Cleared
Jun 20, 1995
ORGENTEC ANTI-TPO ELISA
Immunology
43d
Cleared
Jun 20, 1995
ORGENTEC ANTI-TG ELISA
Immunology
43d
Cleared
Apr 24, 1995
ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY)
Immunology
95d
Cleared
Apr 21, 1995
ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY)
Immunology
101d
Cleared
Apr 21, 1995
ORGENTEC ANTI-TG PIA (PIN IMMUNO ASSAY)
Immunology
101d
Cleared
Apr 21, 1995
ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY)
Immunology
101d