Cleared Traditional

50NG/ML COCAINE METABOLITE CALIBRATOR

K972835 · Diagnostic Reagents, Inc. · Toxicology
Aug 1997
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K972835 is an FDA 510(k) clearance for the 50NG/ML COCAINE METABOLITE CALIBRATOR, a Calibrators, Drug Specific (Class II — Special Controls, product code DLJ), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 28, 1997, 28 days after receiving the submission on July 31, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K972835 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 1997
Decision Date August 28, 1997
Days to Decision 28 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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