Cleared Traditional

STC DIAGNOSTICS LSD MICRO-PLATE EIA

K954073 · Solarcare Technologies Corp,Inc. · Toxicology
Nov 1995
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K954073 is an FDA 510(k) clearance for the STC DIAGNOSTICS LSD MICRO-PLATE EIA, a Radioimmunoassay, Lsd (125-i) (Class II — Special Controls, product code DLB), submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on November 29, 1995, 91 days after receiving the submission on August 30, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3580.

Submission Details

510(k) Number K954073 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 1995
Decision Date November 29, 1995
Days to Decision 91 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DLB — Radioimmunoassay, Lsd (125-i)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3580

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