Cleared Abbreviated

EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5

K993755 · Syva Co. · Toxicology
Dec 1999
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K993755 is an FDA 510(k) clearance for the EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5, a Calibrators, Drug Mixture (Class II — Special Controls, product code DKB), submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on December 21, 1999, 46 days after receiving the submission on November 5, 1999. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K993755 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 1999
Decision Date December 21, 1999
Days to Decision 46 days
Submission Type Abbreviated
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DKB — Calibrators, Drug Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200

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