KING DIAGNOSTICS HEMOGLOBIN TEST— 510(k) K812127

Name: FDA 510(k) clearance K812127
Creator: U.S. Food and Drug Administration
Published: 1981-08-25

Substantially Equivalent

King Diagnostics, Inc.

FDA 510(k) clearance K812127 for KING DIAGNOSTICS HEMOGLOBIN TEST, Substantially Equivalent on 1981-08-25. Applicant: King Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: King Diagnostics, Inc.
Product code: Code GKR
Device class: Class 2
Regulation: 21 CFR 864.5620
Advisory panel: Hematology
Date received: 1981-07-27
Decision date: 1981-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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