Cleared Traditional

EMIT IIC PHENCYCLIDINE ASSAY

K935191 · Syva Co. · Toxicology
Feb 1995
Decision
484d
Days
—
Risk

About This 510(k) Submission

K935191 is an FDA 510(k) clearance for the EMIT IIC PHENCYCLIDINE ASSAY, a Enzyme Immunoassay, Phencyclidine, submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on February 22, 1995, 484 days after receiving the submission on October 26, 1993. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K935191 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 1993
Decision Date February 22, 1995
Days to Decision 484 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LCM — Enzyme Immunoassay, Phencyclidine
Device Class —

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