Cleared Traditional

K915728 - EMIT D.A.U. PHENCYCLIDINE ASSAY (FDA 510(k) Clearance)

K915728 · Syva Co. · Chemistry device
Jan 1992
Decision
38d
Days
—
Risk

K915728 is an FDA 510(k) clearance for the EMIT D.A.U. PHENCYCLIDINE ASSAY. This device is classified as a Enzyme Immunoassay, Phencyclidine.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on January 27, 1992, 38 days after receiving the submission on December 20, 1991.

This device falls under the Chemistry FDA review panel.

Submission Details

510(k) Number K915728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1991
Decision Date January 27, 1992
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code LCM — Enzyme Immunoassay, Phencyclidine
Device Class —