EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229— 510(k) K010814

Name: FDA 510(k) clearance K010814
Creator: U.S. Food and Drug Administration
Published: 2001-04-13

Substantially Equivalent

Syva Co., Dade Behring, Inc.

FDA 510(k) clearance K010814 for EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229, Substantially Equivalent on 2001-04-13. Applicant: Syva Co., Dade Behring, Inc.. Device class: 2.

Clearance details

Applicant: Syva Co., Dade Behring, Inc.
Product code: Code KLT
Device class: Class 2
Regulation: 21 CFR 862.3645
Advisory panel: Clinical Toxicology
Date received: 2001-03-19
Decision date: 2001-04-13
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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