VARELISA HELICOBACTER PYLORI ANTIBODIES— 510(k) K953873

Name: FDA 510(k) clearance K953873
Creator: U.S. Food and Drug Administration
Published: 1996-08-30

Substantially Equivalent

Elias U.S.A., Inc.

FDA 510(k) clearance K953873 for VARELISA HELICOBACTER PYLORI ANTIBODIES, Substantially Equivalent on 1996-08-30. Applicant: Elias U.S.A., Inc.. Device class: 1.

Clearance details

Applicant: Elias U.S.A., Inc.
Product code: Code LYR
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 1995-08-17
Decision date: 1996-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Osceola, WI, US

Download summary PDF View on FDA.gov ↗

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K953587 — VARELISA MPO-ANCA1996-01-26
K951187 — VARELISA CARDIOLIPIN ABS SCREEN1995-10-02

Adverse events under product code LYR

product code LYR

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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