Cleared Traditional

EMIT HVA PHENCYCLIDINE ASSAY

K882179 · Syva Co. · Toxicology
Jul 1988
Decision
49d
Days
—
Risk

About This 510(k) Submission

K882179 is an FDA 510(k) clearance for the EMIT HVA PHENCYCLIDINE ASSAY, a Radioimmunoassay, Phencyclidine, submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on July 12, 1988, 49 days after receiving the submission on May 24, 1988. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K882179 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 1988
Decision Date July 12, 1988
Days to Decision 49 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code LCL — Radioimmunoassay, Phencyclidine
Device Class —

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