Cleared Traditional

SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL

K994005 · Syva Co. · Chemistry
Jan 2000
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K994005 is an FDA 510(k) clearance for the SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL, a Enzyme Immunoassay, Methadone (Class II — Special Controls, product code DJR), submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on January 20, 2000, 57 days after receiving the submission on November 24, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3620.

Submission Details

510(k) Number K994005 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 1999
Decision Date January 20, 2000
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DJR — Enzyme Immunoassay, Methadone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3620

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