WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001— 510(k) K012326
Substantially EquivalentWiener Laboratories Saic
FDA 510(k) clearance K012326 for WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001, Substantially Equivalent on 2001-11-08. Applicant: Wiener Laboratories Saic. Device class: 1.
Clearance details
- Applicant
- Wiener Laboratories Saic
- Product code
- Code JGJ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1495
- 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.