Cleared Traditional

K800514 - PHENCYCLIDINE DIRECT BLOOD RIA KIT (FDA 510(k) Clearance)

K800514 · Immunalysis Corporation · Toxicology device

Mar 1980

Decision

14d

Days

—

Risk

K800514 is an FDA 510(k) clearance for the PHENCYCLIDINE DIRECT BLOOD RIA KIT. This device is classified as a Radioimmunoassay, Phencyclidine.

Submitted by Immunalysis Corporation (Walker, US). The FDA issued a Cleared decision on March 19, 1980, 14 days after receiving the submission on March 5, 1980.

This device falls under the Toxicology FDA review panel.

Submission Details

510(k) Number	K800514 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 05, 1980
Decision Date	March 19, 1980
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—

Device Classification

Product Code	LCL — Radioimmunoassay, Phencyclidine
Device Class	—