Cleared Traditional

OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I

K013882 · OraSure Technologies, Inc. · Toxicology
Apr 2002
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K013882 is an FDA 510(k) clearance for the OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I, a Enzyme Immunoassay, Benzodiazepine (Class II — Special Controls, product code JXM), submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on April 17, 2002, 145 days after receiving the submission on November 23, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3170.

Submission Details

510(k) Number K013882 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2001
Decision Date April 17, 2002
Days to Decision 145 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code JXM — Enzyme Immunoassay, Benzodiazepine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3170

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