Cleared Traditional

K913864 - PCP DIRECT RIA KIT (I-125) (FDA 510(k) Clearance)

K913864 · Immunalysis Corporation · Toxicology device

Oct 1991

Decision

45d

Days

—

Risk

K913864 is an FDA 510(k) clearance for the PCP DIRECT RIA KIT (I-125). This device is classified as a Radioimmunoassay, Phencyclidine.

Submitted by Immunalysis Corporation (Glendale, US). The FDA issued a Cleared decision on October 11, 1991, 45 days after receiving the submission on August 27, 1991.

This device falls under the Toxicology FDA review panel.

Submission Details

510(k) Number	K913864 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 27, 1991
Decision Date	October 11, 1991
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Statement

Device Classification

Product Code	LCL — Radioimmunoassay, Phencyclidine
Device Class	—