Cleared Traditional

BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2

K132090 · Randox Laboratories, Ltd. · Toxicology
Aug 2013
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K132090 is an FDA 510(k) clearance for the BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2, a Calibrators, Drug Specific (Class II — Special Controls, product code DLJ), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on August 8, 2013, 27 days after receiving the submission on July 12, 2013. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K132090 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2013
Decision Date August 08, 2013
Days to Decision 27 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

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

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