ANTIBODY TO MUMPS VIRUS IFA TEST— 510(k) K822826

Name: FDA 510(k) clearance K822826
Creator: U.S. Food and Drug Administration
Published: 1982-12-03

Substantially Equivalent

Electro-Nucleonics Laboratories, Inc.

FDA 510(k) clearance K822826 for ANTIBODY TO MUMPS VIRUS IFA TEST, Substantially Equivalent on 1982-12-03. Applicant: Electro-Nucleonics Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Electro-Nucleonics Laboratories, Inc.
Product code: Code GRA
Device class: Class 1
Regulation: 21 CFR 866.3380
Advisory panel: Microbiology
Date received: 1982-09-21
Decision date: 1982-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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