WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003— 510(k) K013097
Substantially EquivalentWiener Laboratories Saic
FDA 510(k) clearance K013097 for WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003, Substantially Equivalent on 2001-11-13. Applicant: Wiener Laboratories Saic. Device class: 1.
Clearance details
- Applicant
- Wiener Laboratories Saic
- Product code
- Code JIY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1410
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rosario, Santa Fe, AR
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Data sourced from openFDA. This site is unofficial and independent of the FDA.