OSOM ULTRA STREP A TEST, MODEL 147— 510(k) K992658

Name: FDA 510(k) clearance K992658
Creator: U.S. Food and Drug Administration
Published: 2000-01-18

Substantially Equivalent

Wyntek Diagnostics, Inc.

FDA 510(k) clearance K992658 for OSOM ULTRA STREP A TEST, MODEL 147, Substantially Equivalent on 2000-01-18. Applicant: Wyntek Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Wyntek Diagnostics, Inc.
Product code: Code GTY
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 1999-08-09
Decision date: 2000-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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.