Cleared Traditional

SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL

K993981 · Syva Co. · Toxicology
Feb 2000
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K993981 is an FDA 510(k) clearance for the SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL, a Enzyme Immunoassay, Propoxyphene (Class II — Special Controls, product code JXN), submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on February 1, 2000, 69 days after receiving the submission on November 24, 1999. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3700.

Submission Details

510(k) Number K993981 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 1999
Decision Date February 01, 2000
Days to Decision 69 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code JXN — Enzyme Immunoassay, Propoxyphene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3700

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