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American Laboratory Products Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
27
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K012576CIC-C1Q EIAJanuary 29, 2002
K011415ALPCO MILENIA ANTI-TG EIAMay 30, 2001
K011201ALPCO MILENIA ANTI-TPO ELISAMay 24, 2001
K974702ORGENTEC ANTI-PR3 (C-ANCA) ELISAFebruary 17, 1998
K974701ORGENTEC ANTI-MPO (P-ANCA) ELISAFebruary 17, 1998
K972190THYROGLOBULIN ASSAY SYSTEMJuly 14, 1997
K970932ORGENTEC MICRO-ALBUMIN EIA ASSAYApril 8, 1997
K962062ORGENTEC ANTI-SM ELISANovember 18, 1996
K962057ORGENTEC ANTI-RNP/SM ELISANovember 18, 1996
K962052ORGENTEC ABTI-SS-BB(LA) ELISANovember 15, 1996
K962053ORGENTEC ANTI-JO-1 ELISANovember 15, 1996
K962054ORGENTEC ANTI-SS-A(RO) ELISANovember 15, 1996
K962055ORGENTEC ANTI-SCL 70 ELISANovember 15, 1996
K963911ALPCO/MERCODIA INSULIN ELISANovember 1, 1996
K962926ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAYOctober 10, 1996
K962469ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAYSeptember 9, 1996
K955449ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAYMay 23, 1996
K955561BUHLMANN VITAMIN B6 REAMay 23, 1996
K952055ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAYJuly 18, 1995
K952129ORGENTEC ANTI-TPO ELISAJune 20, 1995