FDA 510(k)
FDA class 1
Substantially Equivalent
🇦🇷 Argentina
WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105
K Number: K010421
·
Decision Apr 13, 2001
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
117
Applicant Total
24
Review Days
60
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Basic Information
- Device Name
- WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105
- K Number
- K010421
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wiener Laboratories Saic
- Date Received
- February 12, 2001
- Decision Date
- April 13, 2001
- Product Code
- KNK
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNK | Acid, Uric, Uricase (Colorimetric) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Wiener Laboratories Saic
| K Number | Device Name | ||
|---|---|---|---|
| K023889 | WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 | Feb 11, 2004 | Substantially Equivalent |
| K024305 | WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006 | Mar 18, 2003 | Substantially Equivalent |
| K024116 | WIENER LAB. BILIRUBINA DIRECT AA | Feb 12, 2003 | Substantially Equivalent |
| K023992 | WIENER LAB COLINESTERASA AA | Feb 12, 2003 | Substantially Equivalent |
| K023744 | WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 | Jan 3, 2003 | Substantially Equivalent |
| K023551 | WIENER LAB GOT (AST) UV AA LIQUIDA | Dec 9, 2002 | Substantially Equivalent |
| K023550 | WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA | Dec 9, 2002 | Substantially Equivalent |
| K023549 | WIENER LAB AMILASA 405 AA LIQUIDA | Dec 9, 2002 | Substantially Equivalent |
| K022962 | WIENER LAB. BILIRRUBINA TOTAL AA | Nov 1, 2002 | 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 | Sep 10, 2002 | Substantially Equivalent |