INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC— 510(k) K051638

Name: FDA 510(k) clearance K051638
Creator: U.S. Food and Drug Administration
Published: 2005-12-06

Substantially Equivalent

Unipath , Ltd.

FDA 510(k) clearance K051638 for INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC, Substantially Equivalent on 2005-12-06. Applicant: Unipath , Ltd.. Device class: 1.

Clearance details

Applicant: Unipath , Ltd.
Product code: Code GTY
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 2005-06-20
Decision date: 2005-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, GB

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GTY

product code GTY

Death: 2
Total: 2

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.