HEP-2 CELLS— 510(k) K842834

Name: FDA 510(k) clearance K842834
Creator: U.S. Food and Drug Administration
Published: 1984-08-28

Substantially Equivalent

Bartels Immunodiagnostic Supplies, Inc.

FDA 510(k) clearance K842834 for HEP-2 CELLS, Substantially Equivalent on 1984-08-28. Applicant: Bartels Immunodiagnostic Supplies, Inc.. Device class: 1.

Clearance details

Applicant: Bartels Immunodiagnostic Supplies, Inc.
Product code: Code KJR
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1984-07-20
Decision date: 1984-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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