WIENER LAB. BILIRRUBINA TOTAL AA— 510(k) K022962
Substantially EquivalentWiener Laboratories Saic
FDA 510(k) clearance K022962 for WIENER LAB. BILIRRUBINA TOTAL AA, Substantially Equivalent on 2002-11-01. Applicant: Wiener Laboratories Saic. Device class: 2.
Clearance details
- Applicant
- Wiener Laboratories Saic
- Product code
- Code CIG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1110
- 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.