GENERIC BLOOD GLUCOSE TEST STRIP— 510(k) K001092

Name: FDA 510(k) clearance K001092
Creator: U.S. Food and Drug Administration
Published: 2000-07-26

Substantially Equivalent

Inbios Intl., Inc.

FDA 510(k) clearance K001092 for GENERIC BLOOD GLUCOSE TEST STRIP, Substantially Equivalent on 2000-07-26. Applicant: Inbios Intl., Inc.. Device class: 2.

Clearance details

Applicant: Inbios Intl., Inc.
Product code: Code CGA
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 2000-04-04
Decision date: 2000-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

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.