Cleared Traditional

STC CANNABINOIDS MICRO-PLATE EIA

K973750 · OraSure Technologies, Inc. · Toxicology
Feb 1998
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K973750 is an FDA 510(k) clearance for the STC CANNABINOIDS MICRO-PLATE EIA, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on February 13, 1998, 135 days after receiving the submission on October 1, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K973750 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 1997
Decision Date February 13, 1998
Days to Decision 135 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LDJ — Enzyme Immunoassay, Cannabinoids
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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