ENTEROVIRUS 71 MONOCLONAL ANTIBODY— 510(k) K940473

Name: FDA 510(k) clearance K940473
Creator: U.S. Food and Drug Administration
Published: 1995-09-12

Substantially Equivalent

Chemicon Intl., Inc.

FDA 510(k) clearance K940473 for ENTEROVIRUS 71 MONOCLONAL ANTIBODY, Substantially Equivalent on 1995-09-12. Applicant: Chemicon Intl., Inc.. Device class: 1.

Clearance details

Applicant: Chemicon Intl., Inc.
Product code: Code GOE
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1994-02-02
Decision date: 1995-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.