AMER. HISTO-ID SYS PRIMARY IGM S7920-31— 510(k) K842327

Name: FDA 510(k) clearance K842327
Creator: U.S. Food and Drug Administration
Published: 1984-08-02

Substantially Equivalent

Bartels Immunodiagnostic Supplies, Inc.

FDA 510(k) clearance K842327 for AMER. HISTO-ID SYS PRIMARY IGM S7920-31, Substantially Equivalent on 1984-08-02. Applicant: Bartels Immunodiagnostic Supplies, Inc.. Device class: 2.

Clearance details

Applicant: Bartels Immunodiagnostic Supplies, Inc.
Product code: Code DFT
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1984-06-13
Decision date: 1984-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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