CHOLESTEROL DETERMINATION— 510(k) K871260

Name: FDA 510(k) clearance K871260
Creator: U.S. Food and Drug Administration
Published: 1987-04-13

Substantially Equivalent

Biochemical Trade, Inc.

FDA 510(k) clearance K871260 for CHOLESTEROL DETERMINATION, Substantially Equivalent on 1987-04-13. Applicant: Biochemical Trade, Inc.. Device class: 1.

Clearance details

Applicant: Biochemical Trade, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1987-03-31
Decision date: 1987-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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