Cleared Traditional

MODIFICATION OF EMIT D.A.U. OPIATES ASSAY

K984232 · Syva Co. · Toxicology
Jan 1999
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K984232 is an FDA 510(k) clearance for the MODIFICATION OF EMIT D.A.U. OPIATES ASSAY, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on January 22, 1999, 58 days after receiving the submission on November 25, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K984232 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 1998
Decision Date January 22, 1999
Days to Decision 58 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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