Cleared Traditional

K093989 - ORAL FLUID PHENCYCLIDINE (FDA 510(k) Clearance)

K093989 · Roche Diagnostics · Chemistry device

Jan 2011

Decision

397d

Days

—

Risk

K093989 is an FDA 510(k) clearance for the ORAL FLUID PHENCYCLIDINE. This device is classified as a Enzyme Immunoassay, Phencyclidine.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on January 25, 2011, 397 days after receiving the submission on December 24, 2009.

This device falls under the Chemistry FDA review panel.

Submission Details

510(k) Number	K093989 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 24, 2009
Decision Date	January 25, 2011
Days to Decision	397 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF