Cleared Special

EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229

K011347 · Syva Co. · Toxicology
May 2001
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K011347 is an FDA 510(k) clearance for the EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229, a Enzyme Immunoassay, Diphenylhydantoin (Class II — Special Controls, product code DIP), submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on May 17, 2001, 15 days after receiving the submission on May 2, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number K011347 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2001
Decision Date May 17, 2001
Days to Decision 15 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIP — Enzyme Immunoassay, Diphenylhydantoin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3350

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