PRODUCT #K3002 KETOTROL-N(URINE CONTROL)— 510(k) K760863

Name: FDA 510(k) clearance K760863
Creator: U.S. Food and Drug Administration
Published: 1976-11-02

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K760863 for PRODUCT #K3002 KETOTROL-N(URINE CONTROL), Substantially Equivalent on 1976-11-02. Applicant: Sigma Chemical Co.. Device class: 1.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code JJW
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1976-10-18
Decision date: 1976-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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