Cleared Traditional

AUTO-LYTE BARBITURATES EIA

K982745 · OraSure Technologies, Inc. · Toxicology
Nov 1998
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K982745 is an FDA 510(k) clearance for the AUTO-LYTE BARBITURATES EIA, a Enzyme Immunoassay, Barbiturate (Class II — Special Controls, product code DIS), submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on November 18, 1998, 104 days after receiving the submission on August 6, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K982745 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 1998
Decision Date November 18, 1998
Days to Decision 104 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DIS — Enzyme Immunoassay, Barbiturate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3150

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