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Wiener Laboratories Saic

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
24
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K023889WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254February 11, 2004
K024305WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006March 18, 2003
K024116WIENER LAB. BILIRUBINA DIRECT AAFebruary 12, 2003
K023992WIENER LAB COLINESTERASA AAFebruary 12, 2003
K023744WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354January 3, 2003
K023549WIENER LAB AMILASA 405 AA LIQUIDADecember 9, 2002
K023550WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDADecember 9, 2002
K023551WIENER LAB GOT (AST) UV AA LIQUIDADecember 9, 2002
K022962WIENER LAB. BILIRRUBINA TOTAL AANovember 1, 2002
K021334WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO IISeptember 10, 2002
K021332WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UVJuly 3, 2002
K013983WIENER LAB. ALP 405January 28, 2002
K013652WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002December 21, 2001
K011953WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER December 21, 2001
K013145WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 ANNovember 27, 2001
K013095WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311November 16, 2001
K013101WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINENovember 16, 2001
K013097WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003November 13, 2001
K013102WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002November 13, 2001
K012326WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001November 8, 2001