Wiener Laboratories Saic
Rosario, Santa Fe, AR
Wiener Laboratories Saic appears in FDA device records in Rosario, Santa Fe, AR. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 24
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 24 510(k) clearances for Wiener Laboratories Saic between 2001 and 2004. The busiest year on record is 2001, with 12. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 12 |
| 2002 | 7 |
| 2003 | 4 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K023889 | WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 | MIU | Substantially Equivalent | |
| K024305 | WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006 | JIX | Substantially Equivalent | |
| K024116 | WIENER LAB. BILIRUBINA DIRECT AA | CIG | Substantially Equivalent | |
| K023992 | WIENER LAB COLINESTERASA AA | DIH | Substantially Equivalent | |
| K023744 | WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 | JHW | Substantially Equivalent | |
| K023551 | WIENER LAB GOT (AST) UV AA LIQUIDA | CIT | Substantially Equivalent | |
| K023550 | WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA | KNK | Substantially Equivalent | |
| K023549 | WIENER LAB AMILASA 405 AA LIQUIDA | JFJ | Substantially Equivalent | |
| K022962 | WIENER LAB. BILIRRUBINA TOTAL AA | CIG | Substantially Equivalent | |
| 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 | CJY | Substantially Equivalent | |
| 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 | CGS | Substantially Equivalent | |
| K013983 | WIENER LAB. ALP 405 | CJE | Substantially Equivalent | |
| K013652 | WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 | CIC | Substantially Equivalent | |
| K011953 | WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA | CGA | Substantially Equivalent | |
| 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. | CIT | Substantially Equivalent | |
| K013101 | WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA | JFJ | Substantially Equivalent | |
| K013095 | WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 | CEO | Substantially Equivalent | |
| K013102 | WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 | JMO | Substantially Equivalent | |
| K013097 | WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 | JIY | Substantially Equivalent | |
| K012326 | WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 | JGJ | Substantially Equivalent | |
| K012065 | WIENER LAB. CREATININA CINETICA AA | JFY | Substantially Equivalent | |
| K012329 | WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300 | CIX | Substantially Equivalent | |
| K012260 | WIENER LAB. UREA UV CINETICA AA | CDQ | Substantially Equivalent | |
| K010421 | WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 | KNK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNKAcid, Uric, Uricase (Colorimetric)
- CJYAzo Dye, Calcium
- CIXBromcresol Green Dye-Binding, Albumin
- JIXCalibrator, Multi-Analyte Mixture
- JFJCatalytic Methods, Amylase
- DIHColorimetry, Cholinesterase
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- JFYEnzymatic Method, Creatinine
- MIUEnzyme Linked Immunosorbent Assay, T. Cruzi
- JMOFerrozine (Colorimetric) Iron Binding Capacity
- CGAGlucose Oxidase, Glucose
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIYPhotometric Method, Iron (Non-Heme)
- JGJPhotometric Method, Magnesium
- JHWU.V. Method, Cpk Isoenzymes
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Wiener Laboratories Saic edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Wiener Laboratories Saic. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain