DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD— 510(k) K911056

Clearance details

Applicant

E.I. Dupont DE Nemours & Co., Inc.

Product code

Code DIP

Device class

Class 2

Regulation

21 CFR 862.3350

Advisory panel

Clinical Toxicology

Date received

1991-03-08

Decision date

1991-04-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Wilmington, DE, US

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• Z-0148-2015 — siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma. PTN test results are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20140924

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K911056.