HELISAL RAPID BLOOD TEST— 510(k) K953686

Name: FDA 510(k) clearance K953686
Creator: U.S. Food and Drug Administration
Published: 1996-05-21

Substantially Equivalent

Cortecs, Ltd.

FDA 510(k) clearance K953686 for HELISAL RAPID BLOOD TEST, Substantially Equivalent on 1996-05-21. Applicant: Cortecs, Ltd.. Device class: 1.

Clearance details

Applicant: Cortecs, Ltd.
Product code: Code LYR
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 1995-07-31
Decision date: 1996-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Cadwell, NJ, US

Download summary PDF View on FDA.gov ↗

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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.