CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC— 510(k) K790556

Name: FDA 510(k) clearance K790556
Creator: U.S. Food and Drug Administration
Published: 1979-05-07

Substantially Equivalent

Calbiochem-Behring Corp.

FDA 510(k) clearance K790556 for CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC, Substantially Equivalent on 1979-05-07. Applicant: Calbiochem-Behring Corp.. Device class: 1.

Clearance details

Applicant: Calbiochem-Behring Corp.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1979-03-19
Decision date: 1979-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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