Cleared Traditional

QMS TM- PHENYTOIN

K904815 · Seradyn, Inc. · Chemistry
Nov 1990
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K904815 is an FDA 510(k) clearance for the QMS TM- PHENYTOIN, a Enzyme Immunoassay, Diphenylhydantoin (Class II — Special Controls, product code DIP), submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 6, 1990, 13 days after receiving the submission on October 24, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number K904815 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 1990
Decision Date November 06, 1990
Days to Decision 13 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code DIP — Enzyme Immunoassay, Diphenylhydantoin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3350

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