WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR.— 510(k) K013145
Substantially EquivalentWiener Laboratories Saic
FDA 510(k) clearance K013145 for WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR., Substantially Equivalent on 2001-11-27. Applicant: Wiener Laboratories Saic. Device class: 2.
Clearance details
- Applicant
- Wiener Laboratories Saic
- Product code
- Code CIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1100
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rosario, Santa Fe, AR
Recent devices under product code CIT
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- K071525 — ACTIVATED ASPARTATE AMINOTRANSFERASE
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More clearances from Wiener Laboratories Saic
view all- K023889 — WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
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- K023992 — WIENER LAB COLINESTERASA AA
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- 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.