HEMAGEN ENA SS-B KIT (EIA METHOD)— 510(k) K946120

Name: FDA 510(k) clearance K946120
Creator: U.S. Food and Drug Administration
Published: 1995-02-22

Substantially Equivalent

Hemagen Diagnostics, Inc.

FDA 510(k) clearance K946120 for HEMAGEN ENA SS-B KIT (EIA METHOD), Substantially Equivalent on 1995-02-22. Applicant: Hemagen Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Hemagen Diagnostics, Inc.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1994-12-15
Decision date: 1995-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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