Cleared Traditional

AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U

K982831 · OraSure Technologies, Inc. · Toxicology
Nov 1998
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K982831 is an FDA 510(k) clearance for the AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U, 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 November 12, 1998, 93 days after receiving the submission on August 11, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3170.

Submission Details

510(k) Number K982831 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 1998
Decision Date November 12, 1998
Days to Decision 93 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

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

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