PRECISET TDM I AND PRECISET TDM II CALIBRATORS— 510(k) K031856

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K031856 for PRECISET TDM I AND PRECISET TDM II CALIBRATORS, Substantially Equivalent on 2003-08-06. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DKB
Advisory panel: Clinical Toxicology
Date received: 2003-06-16
Decision date: 2003-08-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Indianapolis, IN, US

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