Cleared Traditional

STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION

K940048 · Solarcare Technologies Corp,Inc. · Toxicology
Mar 1996
Decision
804d
Days
Class 2
Risk

About This 510(k) Submission

K940048 is an FDA 510(k) clearance for the STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION, a Calibrators, Drug Specific (Class II — Special Controls, product code DLJ), submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on March 19, 1996, 804 days after receiving the submission on January 5, 1994. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K940048 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 1994
Decision Date March 19, 1996
Days to Decision 804 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DLJ — Calibrators, Drug Specific
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200

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