Cleared Traditional

STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I

K001976 · OraSure Technologies, Inc. · Toxicology
Dec 2000
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K001976 is an FDA 510(k) clearance for the STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I, 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 December 6, 2000, 160 days after receiving the submission on June 29, 2000. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K001976 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2000
Decision Date December 06, 2000
Days to Decision 160 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

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

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