Cleared Special

K001197 - COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA
(FDA 510(k) Clearance)

K001197 · OraSure Technologies, Inc. · Toxicology

May 2000

Decision

30d

Days

Class 2

Risk

K001197 is an FDA 510(k) clearance for the COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA. This device is classified as a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO).

Submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on May 11, 2000, 30 days after receiving the submission on April 11, 2000.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number	K001197 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 11, 2000
Decision Date	May 11, 2000
Days to Decision	30 days
Submission Type	Special
Review Panel	Toxicology (TX)
Summary	Summary PDF