ENZYGNOST F 1+2— 510(k) K922934

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K922934 for ENZYGNOST F 1+2, Substantially Equivalent on 1992-11-16. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code MIF
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 1992-06-18
Decision date: 1992-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

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