HAEM-C PLUS BLOOD REFERENCE CONTROLS— 510(k) K821956

Name: FDA 510(k) clearance K821956
Creator: U.S. Food and Drug Administration
Published: 1982-07-30

Substantially Equivalent

Baker Instructions Corp.

FDA 510(k) clearance K821956 for HAEM-C PLUS BLOOD REFERENCE CONTROLS, Substantially Equivalent on 1982-07-30. Applicant: Baker Instructions Corp.. Device class: 2.

Clearance details

Applicant: Baker Instructions Corp.
Product code: Code JCN
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1982-06-30
Decision date: 1982-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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