WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254— 510(k) K023889

Name: FDA 510(k) clearance K023889
Creator: U.S. Food and Drug Administration
Published: 2004-02-11

Substantially Equivalent

Wiener Laboratories Saic

FDA 510(k) clearance K023889 for WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254, Substantially Equivalent on 2004-02-11. Applicant: Wiener Laboratories Saic. Device class: 1.

Clearance details

Applicant: Wiener Laboratories Saic
Product code: Code MIU
Device class: Class 1
Regulation: 21 CFR 866.3870
Advisory panel: Microbiology
Date received: 2002-11-21
Decision date: 2004-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rosario, Santa Fe, AR

Download summary PDF View on FDA.gov ↗

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Recalls naming K023889

K-number listed on FDA's recall record

Z-0924-2018 — Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.Class II·Ongoing·Wiener Laboratories·20171110

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023889.

Data sourced from openFDA. This site is unofficial and independent of the FDA.