HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT— 510(k) K811714

Name: FDA 510(k) clearance K811714
Creator: U.S. Food and Drug Administration
Published: 1981-07-10

Substantially Equivalent

Scripps-Miles, Inc.

FDA 510(k) clearance K811714 for HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT, Substantially Equivalent on 1981-07-10. Applicant: Scripps-Miles, Inc.. Device class: 2.

Clearance details

Applicant: Scripps-Miles, Inc.
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1981-06-17
Decision date: 1981-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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