Cleared Traditional

STC DIAGNOSTICS AUTO-LYTE(TM) PCP EIA

K924462 · Solarcare Technologies Corp,Inc. · Toxicology
Nov 1992
Decision
61d
Days
—
Risk

About This 510(k) Submission

K924462 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO-LYTE(TM) PCP EIA, a Enzyme Immunoassay, Phencyclidine, submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on November 2, 1992, 61 days after receiving the submission on September 2, 1992. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K924462 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 1992
Decision Date November 02, 1992
Days to Decision 61 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LCM — Enzyme Immunoassay, Phencyclidine
Device Class —

Similar Devices — LCM Enzyme Immunoassay, Phencyclidine

All 87
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair
K212952 · Psychemedics Corporation · Apr 2022
SEFRIA PCP Oral Fluid Enzyme Immunoassay
K203489 · Immunalysis Corporation · Apr 2021
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
K181135 · Immunalysis Corporation · Jan 2019
Atellica CH Phencyclidine (Pcp)
K163220 · Siemens Healthcare Diagnostics, Inc. · Apr 2017
Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K152176 · Immunalysis Corporation · Sep 2015
CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE
K142044 · Guangzhou Wondfo Biotech Co., Ltd. · Aug 2014