PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS— 510(k) K033246

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K033246 for PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS, Substantially Equivalent on 2003-12-02. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DLJ
Advisory panel: Clinical Toxicology
Date received: 2003-10-07
Decision date: 2003-12-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Indianapolis, IN, US

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