Cleared Traditional

AED CALIBRATORS

K961273 · Diagnostic Reagents, Inc. · Toxicology
May 1996
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K961273 is an FDA 510(k) clearance for the AED CALIBRATORS, 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 15, 1996, 43 days after receiving the submission on April 2, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K961273 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 1996
Decision Date May 15, 1996
Days to Decision 43 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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