Cleared Traditional

EMIT IIC BARBITURATE ASSAY

K935116 · Syva Co. · Toxicology
Feb 1995
Decision
483d
Days
Class 2
Risk

About This 510(k) Submission

K935116 is an FDA 510(k) clearance for the EMIT IIC BARBITURATE ASSAY, a Enzyme Immunoassay, Barbiturate (Class II — Special Controls, product code DIS), submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on February 22, 1995, 483 days after receiving the submission on October 27, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K935116 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 1993
Decision Date February 22, 1995
Days to Decision 483 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIS — Enzyme Immunoassay, Barbiturate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3150

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