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— 510(k) K021334
Substantially EquivalentWiener Laboratories Saic
FDA 510(k) clearance K021334 for 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, Substantially Equivalent on 2002-09-10. Applicant: Wiener Laboratories Saic. Device class: 2.
Clearance details
- Applicant
- Wiener Laboratories Saic
- Product code
- Code CJY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1145
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rosario, Santa Fe, AR
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