ENZYGNOST ANTI-CMV IGM TEST— 510(k) K861363

Name: FDA 510(k) clearance K861363
Creator: U.S. Food and Drug Administration
Published: 1986-07-21

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K861363 for ENZYGNOST ANTI-CMV IGM TEST, Substantially Equivalent on 1986-07-21. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code LKQ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1986-04-10
Decision date: 1986-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Jolla, CA, US

Download summary PDF View on FDA.gov ↗

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