PLATO 3300/1300— 510(k) K943454

Substantially Equivalent

Rosys, Inc.

FDA 510(k) clearance K943454 for PLATO 3300/1300, Substantially Equivalent on 1995-01-09. Applicant: Rosys, Inc.. Device class: 1.

Clearance details

Applicant: Rosys, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1994-07-18
Decision date: 1995-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

Download summary PDF View on FDA.gov ↗

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