Cleared Traditional

STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)

K981341 · OraSure Technologies, Inc. · Toxicology
May 1998
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K981341 is an FDA 510(k) clearance for the STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION), a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on May 22, 1998, 39 days after receiving the submission on April 13, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K981341 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 1998
Decision Date May 22, 1998
Days to Decision 39 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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