ENZYGNOST ANTI-CMV/IGG + IGM— 510(k) K901485

Name: FDA 510(k) clearance K901485
Creator: U.S. Food and Drug Administration
Published: 1991-05-20

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K901485 for ENZYGNOST ANTI-CMV/IGG + IGM, Substantially Equivalent on 1991-05-20. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1990-03-29
Decision date: 1991-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

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