CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY— 510(k) K964765

Name: FDA 510(k) clearance K964765
Creator: U.S. Food and Drug Administration
Published: 1997-02-14

Substantially Equivalent

Chiron Diagnostics Corp.

FDA 510(k) clearance K964765 for CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY, Substantially Equivalent on 1997-02-14. Applicant: Chiron Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Chiron Diagnostics Corp.
Product code: Code KLT
Device class: Class 2
Regulation: 21 CFR 862.3645
Advisory panel: Clinical Toxicology
Date received: 1996-11-27
Decision date: 1997-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

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