WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA— 510(k) K021332
Substantially EquivalentWiener Laboratories Saic
FDA 510(k) clearance K021332 for WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA, Substantially Equivalent on 2002-07-03. Applicant: Wiener Laboratories Saic. Device class: 2.
Clearance details
- Applicant
- Wiener Laboratories Saic
- Product code
- Code CGS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rosario, Santa Fe, AR
Recent devices under product code CGS
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view all- K023889 — WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
- K024305 — WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006
- K023992 — WIENER LAB COLINESTERASA AA
- K024116 — WIENER LAB. BILIRUBINA DIRECT AA
- K023744 — WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354
Data sourced from openFDA. This site is unofficial and independent of the FDA.