BILIRUBIN(TOTAL) DETERMINATION CTMS— 510(k) K820675

Name: FDA 510(k) clearance K820675
Creator: U.S. Food and Drug Administration
Published: 1982-04-01

Substantially Equivalent

The Dow Chemical Co.

FDA 510(k) clearance K820675 for BILIRUBIN(TOTAL) DETERMINATION CTMS, Substantially Equivalent on 1982-04-01. Applicant: The Dow Chemical Co.. Device class: 2.

Clearance details

Applicant: The Dow Chemical Co.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1982-03-11
Decision date: 1982-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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