Cleared Traditional

K882179 - EMIT HVA PHENCYCLIDINE ASSAY (FDA 510(k) Clearance)

Jul 1988
Decision
49d
Days
Risk

K882179 is an FDA 510(k) clearance for the EMIT HVA PHENCYCLIDINE ASSAY. This device is classified as 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 FDA review panel.

Submission Details

510(k) Number K882179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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