Cleared Special

AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C

K994093 · Phamatech · Toxicology
Dec 1999
Decision
13d
Days
—
Risk

About This 510(k) Submission

K994093 is an FDA 510(k) clearance for the AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C, a Radioimmunoassay, Phencyclidine, submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on December 16, 1999, 13 days after receiving the submission on December 3, 1999. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K994093 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 1999
Decision Date December 16, 1999
Days to Decision 13 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LCL — Radioimmunoassay, Phencyclidine
Device Class —

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