Cleared Traditional

EMIT 2000 DIGOXIN ASSAY

K951755 · Syva Co. · Chemistry
Jun 1995
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K951755 is an FDA 510(k) clearance for the EMIT 2000 DIGOXIN ASSAY, a Enzyme Immunoassay, Digoxin (Class II — Special Controls, product code KXT), submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on June 1, 1995, 45 days after receiving the submission on April 17, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K951755 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 1995
Decision Date June 01, 1995
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KXT — Enzyme Immunoassay, Digoxin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320

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