Cleared Traditional

EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT

K901080 · Immunotech Corp. · Chemistry
May 1990
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K901080 is an FDA 510(k) clearance for the EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT, a Enzyme Immunoassay, Diphenylhydantoin (Class II — Special Controls, product code DIP), submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on May 17, 1990, 71 days after receiving the submission on March 7, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number K901080 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 1990
Decision Date May 17, 1990
Days to Decision 71 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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