Cleared Traditional

STC DIAGNOSTICS AUTO-LYTE AMPHETAMINES EIA

K930690 · Solarcare Technologies Corp,Inc. · Toxicology
Apr 1993
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K930690 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO-LYTE AMPHETAMINES EIA, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on April 16, 1993, 65 days after receiving the submission on February 10, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K930690 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 1993
Decision Date April 16, 1993
Days to Decision 65 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

Similar Devices — DKZ Enzyme Immunoassay, Amphetamine

All 224
DRI Ecstasy Plus Assay
K240670 · Microgenics Corporation · Oct 2024
AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx
K233019 · Hangzhou AllTest Biotech Co., Ltd. · Dec 2023
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
K231137 · Xenta Biomedical Science Co., Ltd. · May 2023
Quidel Triage? TOX Drug Screen, 94600
K200363 · Quidel Cardiovascular, Inc. · Mar 2020
Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
K191099 · Atlas Medical · Oct 2019
Quidel Triage TOX Drug Screen, 94600; Quidel Triage? MeterPro
K182719 · Quidel Cardiovascular, Inc. · Jun 2019