PHENYTOIN, AS PERFORMED ON TECHNICON RA SYSTEMS— 510(k) K863403

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K863403 for PHENYTOIN, AS PERFORMED ON TECHNICON RA SYSTEMS, Substantially Equivalent on 1986-09-29. Applicant: Technicon Instruments Corp.. Device class: 2.

Clearance details

Applicant
Technicon Instruments Corp.
Product code
Code DIP
Device class
Class 2
Regulation
21 CFR 862.3350
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tarrytown, NY, US
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