SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS— 510(k) K000600

Name: FDA 510(k) clearance K000600
Creator: U.S. Food and Drug Administration
Published: 2000-03-27

Substantially Equivalent

Syva Co., Dade Behring, Inc.

FDA 510(k) clearance K000600 for SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS, Substantially Equivalent on 2000-03-27. Applicant: Syva Co., Dade Behring, Inc.. Device class: 2.

Clearance details

Applicant: Syva Co., Dade Behring, Inc.
Product code: Code KLI
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 2000-02-23
Decision date: 2000-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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