CYTOSCAN— 510(k) K864955

Substantially Equivalent

Image Recognition Systems , Ltd.

FDA 510(k) clearance K864955 for CYTOSCAN, Substantially Equivalent on 1987-03-16. Applicant: Image Recognition Systems , Ltd.. Device class: 2.

Clearance details

Applicant: Image Recognition Systems , Ltd.
Product code: Code LNJ
Device class: Class 2
Regulation: 21 CFR 864.5260
Advisory panel: Hematology
Date received: 1986-12-18
Decision date: 1987-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warrington, Cheshire, GB

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