Cleared Traditional

K043305 - ONLINE DAT PHENCYCLIDINE PLUS (FDA 510(k) Clearance)

K043305 · Roche Diagnostics Corp. · Toxicology device

Jan 2005

Decision

41d

Days

—

Risk

K043305 is an FDA 510(k) clearance for the ONLINE DAT PHENCYCLIDINE PLUS. This device is classified as a Enzyme Immunoassay, Phencyclidine.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 10, 2005, 41 days after receiving the submission on November 30, 2004.

This device falls under the Toxicology FDA review panel.

Submission Details

510(k) Number	K043305 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 30, 2004
Decision Date	January 10, 2005
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF