WIENER LAB. CREATININA CINETICA AA— 510(k) K012065
Substantially EquivalentWiener Laboratories Saic
FDA 510(k) clearance K012065 for WIENER LAB. CREATININA CINETICA AA, Substantially Equivalent on 2001-10-10. Applicant: Wiener Laboratories Saic. Device class: 2.
Clearance details
- Applicant
- Wiener Laboratories Saic
- Product code
- Code JFY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rosario, Santa Fe, AR
Recent devices under product code JFY
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- K023992 — WIENER LAB COLINESTERASA AA
- K024116 — WIENER LAB. BILIRUBINA DIRECT AA
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Data sourced from openFDA. This site is unofficial and independent of the FDA.