Cleared Traditional

SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL

K993983 · Syva Co. · Toxicology
Jan 2000
Decision
64d
Days
—
Risk

About This 510(k) Submission

K993983 is an FDA 510(k) clearance for the SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL, a Enzyme Immunoassay, Phencyclidine, submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on January 27, 2000, 64 days after receiving the submission on November 24, 1999. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K993983 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 1999
Decision Date January 27, 2000
Days to Decision 64 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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