STREPSLIDE— 510(k) K882811

Name: FDA 510(k) clearance K882811
Creator: U.S. Food and Drug Administration
Published: 1988-10-25

Substantially Equivalent

Ncs Diagnostics, Inc.

FDA 510(k) clearance K882811 for STREPSLIDE, Substantially Equivalent on 1988-10-25. Applicant: Ncs Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Ncs Diagnostics, Inc.
Product code: Code GTY
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 1988-07-07
Decision date: 1988-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, L4z 1y6, CA

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.