Cleared Traditional

MICRO-PLATE OPIATES ASSAY

K924446 · Solarcare Technologies Corp,Inc. · Toxicology
Oct 1992
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K924446 is an FDA 510(k) clearance for the MICRO-PLATE OPIATES ASSAY, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on October 15, 1992, 44 days after receiving the submission on September 1, 1992. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K924446 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 1992
Decision Date October 15, 1992
Days to Decision 44 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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