Cleared Traditional

AUTO-LYTE METHADONE DIA

K944056 · Solarcare Technologies Corp,Inc. · Toxicology
Dec 1994
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K944056 is an FDA 510(k) clearance for the AUTO-LYTE METHADONE DIA, a Enzyme Immunoassay, Methadone (Class II — Special Controls, product code DJR), submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on December 29, 1994, 132 days after receiving the submission on August 19, 1994. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3620.

Submission Details

510(k) Number K944056 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1994
Decision Date December 29, 1994
Days to Decision 132 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DJR — Enzyme Immunoassay, Methadone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3620

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