Cleared Traditional

K992918 - STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I
(FDA 510(k) Clearance)

K992918 · OraSure Technologies, Inc. · Toxicology

Apr 2000

Decision

217d

Days

Class 2

Risk

K992918 is an FDA 510(k) clearance for the STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on April 3, 2000, 217 days after receiving the submission on August 30, 1999. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number	K992918 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 30, 1999
Decision Date	April 03, 2000
Days to Decision	217 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF