Cleared Traditional

STC DIAGNOSTICS AUTO-LYTE BENZODIAZEPINES EIA

K934869 · Solarcare Technologies Corp,Inc. · Toxicology
Nov 1993
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K934869 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO-LYTE BENZODIAZEPINES EIA, a Enzyme Immunoassay, Benzodiazepine (Class II — Special Controls, product code JXM), submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on November 22, 1993, 41 days after receiving the submission on October 12, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3170.

Submission Details

510(k) Number K934869 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 1993
Decision Date November 22, 1993
Days to Decision 41 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code JXM — Enzyme Immunoassay, Benzodiazepine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3170

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