DIAG. OZYRATE GLUCOSE REAG. SET— 510(k) K771059

Name: FDA 510(k) clearance K771059
Creator: U.S. Food and Drug Administration
Published: 1977-07-21

Substantially Equivalent

J.T. Baker Chemical Co.

FDA 510(k) clearance K771059 for DIAG. OZYRATE GLUCOSE REAG. SET, Substantially Equivalent on 1977-07-21. Applicant: J.T. Baker Chemical Co.. Device class: 2.

Clearance details

Applicant: J.T. Baker Chemical Co.
Product code: Code CGA
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 1977-06-13
Decision date: 1977-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.