EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229— 510(k) K010960

Name: FDA 510(k) clearance K010960
Creator: U.S. Food and Drug Administration
Published: 2001-04-26

Substantially Equivalent

Syva Co., Dade Behring, Inc.

FDA 510(k) clearance K010960 for EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229, Substantially Equivalent on 2001-04-26. Applicant: Syva Co., Dade Behring, Inc.. Device class: 2.

Clearance details

Applicant: Syva Co., Dade Behring, Inc.
Product code: Code DIC
Device class: Class 2
Regulation: 21 CFR 862.3040
Advisory panel: Clinical Toxicology
Date received: 2001-03-30
Decision date: 2001-04-26
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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