Cleared Traditional

K913865 - URINE THC DIRECT RIA KIT (I-125)
(FDA 510(k) Clearance)

K913865 · Immunalysis Corporation · Toxicology

Sep 1991

Decision

22d

Days

Class 2

Risk

K913865 is an FDA 510(k) clearance for the URINE THC DIRECT RIA KIT (I-125). This device is classified as a Radioimmunoassay, Cannabinoid(s) (Class II — Special Controls, product code LAT).

Submitted by Immunalysis Corporation (Glendale, US). The FDA issued a Cleared decision on September 18, 1991, 22 days after receiving the submission on August 27, 1991.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number	K913865 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 27, 1991
Decision Date	September 18, 1991
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Statement