Cleared Traditional

PCP DIRECT RIA KIT (I-125)

K913864 · Immunalysis Corporation · Toxicology
Oct 1991
Decision
45d
Days
—
Risk

About This 510(k) Submission

K913864 is an FDA 510(k) clearance for the PCP DIRECT RIA KIT (I-125), 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 review panel.

Submission Details

510(k) Number K913864 FDA.gov
FDA Decision Cleared 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 —

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