CYANMETHEMOGLOBIN TEST— 510(k) K820596

Name: FDA 510(k) clearance K820596
Creator: U.S. Food and Drug Administration
Published: 1982-03-26

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K820596 for CYANMETHEMOGLOBIN TEST, Substantially Equivalent on 1982-03-26. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code KHG
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1982-03-04
Decision date: 1982-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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