COBAS REAGENT FOR TRIGLYCERIDES & COBAS— 510(k) K801298

Name: FDA 510(k) clearance K801298
Creator: U.S. Food and Drug Administration
Published: 1980-07-08

Substantially Equivalent

Roche Analytical Instruments, Inc.

FDA 510(k) clearance K801298 for COBAS REAGENT FOR TRIGLYCERIDES & COBAS, Substantially Equivalent on 1980-07-08. Applicant: Roche Analytical Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Roche Analytical Instruments, Inc.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1980-06-02
Decision date: 1980-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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