Cleared Traditional

EMIT IIC CALIBRATORS

K935192 · Syva Co. · Chemistry
Mar 1995
Decision
514d
Days
Class 2
Risk

About This 510(k) Submission

K935192 is an FDA 510(k) clearance for the EMIT IIC CALIBRATORS, 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 March 24, 1995, 514 days after receiving the submission on October 26, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K935192 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 1993
Decision Date March 24, 1995
Days to Decision 514 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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