Medical Device Manufacturer · AR , Rosario, Santa Fe

Wiener Laboratories Saic - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 2001

24

Total

24

Cleared

0

Denied

FDA 510(k) Regulatory Record - Wiener Laboratories Saic Chemistry ✕

23 devices

1-12 of 23

Cleared Mar 18, 2003

WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006

Chemistry · 84d

Cleared Feb 12, 2003

WIENER LAB COLINESTERASA AA

Chemistry · 72d

Cleared Feb 12, 2003

WIENER LAB. BILIRUBINA DIRECT AA

Chemistry · 61d

Cleared Jan 03, 2003

WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354

Chemistry · 57d

Cleared Dec 09, 2002

WIENER LAB AMILASA 405 AA LIQUIDA

Chemistry · 48d

Cleared Dec 09, 2002

WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA

Chemistry · 48d

Cleared Dec 09, 2002

WIENER LAB GOT (AST) UV AA LIQUIDA

Chemistry · 48d

Cleared Nov 01, 2002

WIENER LAB. BILIRRUBINA TOTAL AA

Chemistry · 56d

Cleared Sep 10, 2002

WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER...

Chemistry · 137d

Cleared Jul 03, 2002

WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC...

Chemistry · 68d

Cleared Jan 28, 2002

WIENER LAB. ALP 405

Chemistry · 56d

Cleared Dec 21, 2001

WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106

Chemistry · 183d