Cleared Traditional

AMPHETAMINES MICRO-PLATE EIA

K935573 · Solarcare Technologies Corp,Inc. · Toxicology
Jul 1995
Decision
603d
Days
Class 2
Risk

About This 510(k) Submission

K935573 is an FDA 510(k) clearance for the AMPHETAMINES MICRO-PLATE 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 July 14, 1995, 603 days after receiving the submission on November 18, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K935573 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 1993
Decision Date July 14, 1995
Days to Decision 603 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

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