DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT— 510(k) K810856

Name: FDA 510(k) clearance K810856
Creator: U.S. Food and Drug Administration
Published: 1981-05-05

Substantially Equivalent

Bartels Immunodiagnostic Supplies, Inc.

FDA 510(k) clearance K810856 for DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT, Substantially Equivalent on 1981-05-05. Applicant: Bartels Immunodiagnostic Supplies, Inc.. Device class: 1.

Clearance details

Applicant: Bartels Immunodiagnostic Supplies, Inc.
Product code: Code GPT
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1981-03-30
Decision date: 1981-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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