SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB— 510(k) K920416

Name: FDA 510(k) clearance K920416
Creator: U.S. Food and Drug Administration
Published: 1992-04-08

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K920416 for SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB, Substantially Equivalent on 1992-04-08. Applicant: Behring Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code LIB
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1992-01-31
Decision date: 1992-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

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