Company ยท AR
Wiener Laboratories Saic
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2004. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 2 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 2 |
| JFJ | Catalytic Methods, Amylase | 2 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CJY | Azo Dye, Calcium | 1 |
| DIH | Colorimetry, Cholinesterase | 1 |
| JFY | Enzymatic Method, Creatinine | 1 |
| JGJ | Photometric Method, Magnesium | 1 |
| JHW | U.V. Method, Cpk Isoenzymes | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 |
| JIY | Photometric Method, Iron (Non-Heme) | 1 |
| JMO | Ferrozine (Colorimetric) Iron Binding Capacity | 1 |
| MIU | Enzyme Linked Immunosorbent Assay, T. Cruzi | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 11, 2004 | K023889 | WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 Wiener Laboratories Saic, AR | MIU |
| Mar 18, 2003 | K024305 | WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006 Wiener Laboratories Saic, AR | JIX |
| Feb 12, 2003 | K024116 | WIENER LAB. BILIRUBINA DIRECT AA Wiener Laboratories Saic, AR | CIG |
| Feb 12, 2003 | K023992 | WIENER LAB COLINESTERASA AA Wiener Laboratories Saic, AR | DIH |
| Jan 3, 2003 | K023744 | WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 Wiener Laboratories Saic, AR | JHW |
| Dec 9, 2002 | K023551 | WIENER LAB GOT (AST) UV AA LIQUIDA Wiener Laboratories Saic, AR | CIT |
| Dec 9, 2002 | K023550 | WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA Wiener Laboratories Saic, AR | KNK |
| Dec 9, 2002 | K023549 | WIENER LAB AMILASA 405 AA LIQUIDA Wiener Laboratories Saic, AR | JFJ |
| Nov 1, 2002 | K022962 | WIENER LAB. BILIRRUBINA TOTAL AA Wiener Laboratories Saic, AR | CIG |
| Sep 10, 2002 | K021334 | WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5 Wiener Laboratories Saic, AR | CJY |
| Jul 3, 2002 | K021332 | WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA Wiener Laboratories Saic, AR | CGS |
| Jan 28, 2002 | K013983 | WIENER LAB. ALP 405 Wiener Laboratories Saic, AR | CJE |
| Dec 21, 2001 | K013652 | WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 Wiener Laboratories Saic, AR | CIC |
| Dec 21, 2001 | K011953 | WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA Wiener Laboratories Saic, AR | CGA |
| Nov 27, 2001 | K013145 | WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR. Wiener Laboratories Saic, AR | CIT |
| Nov 16, 2001 | K013101 | WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA Wiener Laboratories Saic, AR | JFJ |
| Nov 16, 2001 | K013095 | WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 Wiener Laboratories Saic, AR | CEO |
| Nov 13, 2001 | K013102 | WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 Wiener Laboratories Saic, AR | JMO |
| Nov 13, 2001 | K013097 | WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 Wiener Laboratories Saic, AR | JIY |
| Nov 8, 2001 | K012326 | WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 Wiener Laboratories Saic, AR | JGJ |
| Oct 10, 2001 | K012065 | WIENER LAB. CREATININA CINETICA AA Wiener Laboratories Saic, AR | JFY |
| Sep 21, 2001 | K012329 | WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300 Wiener Laboratories Saic, AR | CIX |
| Sep 19, 2001 | K012260 | WIENER LAB. UREA UV CINETICA AA Wiener Laboratories Saic, AR | CDQ |
| Apr 13, 2001 | K010421 | WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 Wiener Laboratories Saic, AR | KNK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||