DART PHENYTOIN— 510(k) K880294

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K880294 for DART PHENYTOIN, Substantially Equivalent on 1988-05-27. Applicant: Coulter Electronics, Inc.. Device class: 2.

Clearance details

Applicant: Coulter Electronics, Inc.
Product code: Code LFO
Device class: Class 2
Regulation: 21 CFR 862.3350
Advisory panel: Clinical Toxicology
Date received: 1988-01-25
Decision date: 1988-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

Download summary PDF View on FDA.gov ↗

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K923530 — COULTER MULTI-Q-PREP1992-10-14
K922181 — COULTER MH0091992-08-17

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