Cleared Traditional

K994020 - ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2 (FDA 510(k) Clearance)

K994020 · Roche Diagnostics Corp. · Toxicology device

Jan 2000

Decision

62d

Days

—

Risk

K994020 is an FDA 510(k) clearance for the ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2. This device is classified as a Enzyme Immunoassay, Phencyclidine.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 27, 2000, 62 days after receiving the submission on November 26, 1999.

This device falls under the Toxicology FDA review panel.

Submission Details

510(k) Number	K994020 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 26, 1999
Decision Date	January 27, 2000
Days to Decision	62 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF