Cleared Traditional

AUTO-LYTE PCP EIA, MODEL #1254U

K982801 · OraSure Technologies, Inc. · Toxicology
Nov 1998
Decision
86d
Days
—
Risk

About This 510(k) Submission

K982801 is an FDA 510(k) clearance for the AUTO-LYTE PCP EIA, MODEL #1254U, a Enzyme Immunoassay, Phencyclidine, submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on November 4, 1998, 86 days after receiving the submission on August 10, 1998. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K982801 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 1998
Decision Date November 04, 1998
Days to Decision 86 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LCM — Enzyme Immunoassay, Phencyclidine
Device Class —

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