Cleared Traditional

SERUM TOX CALIBRATOR

K961372 · Diagnostic Reagents, Inc. · Toxicology
May 1996
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K961372 is an FDA 510(k) clearance for the SERUM TOX CALIBRATOR, a Calibrators, Drug Mixture (Class II — Special Controls, product code DKB), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on May 1, 1996, 22 days after receiving the submission on April 9, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K961372 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 1996
Decision Date May 01, 1996
Days to Decision 22 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DKB — Calibrators, Drug Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200

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