EBV(EPSTEIN-BARR VIRUS) TEST KIT— 510(k) K854207

Name: FDA 510(k) clearance K854207
Creator: U.S. Food and Drug Administration
Published: 1986-04-24

Substantially Equivalent

Immuno-Diagnostic Products, Inc.

FDA 510(k) clearance K854207 for EBV(EPSTEIN-BARR VIRUS) TEST KIT, Substantially Equivalent on 1986-04-24. Applicant: Immuno-Diagnostic Products, Inc.. Device class: 1.

Clearance details

Applicant: Immuno-Diagnostic Products, Inc.
Product code: Code GNP
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1985-10-16
Decision date: 1986-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Salt Lake, UT, US

Download summary PDF View on FDA.gov ↗

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