Cleared Traditional

SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

K993980 · Syva Co. · Toxicology
Feb 2000
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K993980 is an FDA 510(k) clearance for the SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL, a Nad-nadh, Specific Reagent For Alcohol Enzyme Method (Class II — Special Controls, product code DML), 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 862.3040.

Submission Details

510(k) Number K993980 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 DML — Nad-nadh, Specific Reagent For Alcohol Enzyme Method
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3040