Cleared Traditional

EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL

K011878 · Syva Co. · Toxicology
Aug 2001
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K011878 is an FDA 510(k) clearance for the EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL, a Colorimetry, Salicylate (Class II — Special Controls, product code DKJ), submitted by Syva Co. (Cupertino, US). The FDA issued a Cleared decision on August 13, 2001, 59 days after receiving the submission on June 15, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3830.

Submission Details

510(k) Number K011878 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2001
Decision Date August 13, 2001
Days to Decision 59 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DKJ — Colorimetry, Salicylate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3830

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