INDIRECT FLUORESCENT (IFA-ANA)— 510(k) K760681

Name: FDA 510(k) clearance K760681
Creator: U.S. Food and Drug Administration
Published: 1976-10-21

Substantially Equivalent

Wampole Laboratories

FDA 510(k) clearance K760681 for INDIRECT FLUORESCENT (IFA-ANA), Substantially Equivalent on 1976-10-21. Applicant: Wampole Laboratories. Device class: 2.

Clearance details

Applicant: Wampole Laboratories
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1976-09-20
Decision date: 1976-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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