Cleared Traditional

ACE PHENYTOIN REAGENT, AED CALIBRATORS

K973414 · Schiapparelli Biosystems, Inc. · Toxicology
Nov 1997
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K973414 is an FDA 510(k) clearance for the ACE PHENYTOIN REAGENT, AED CALIBRATORS, a Enzyme Immunoassay, Diphenylhydantoin (Class II — Special Controls, product code DIP), submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on November 4, 1997, 56 days after receiving the submission on September 9, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number K973414 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 1997
Decision Date November 04, 1997
Days to Decision 56 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

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

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