CHART-TYPE MICRO HEMATOCRIT TUBE READER— 510(k) K870511

Name: FDA 510(k) clearance K870511
Creator: U.S. Food and Drug Administration
Published: 1987-03-16

Substantially Equivalent

Norfolk Scientific, Inc.

FDA 510(k) clearance K870511 for CHART-TYPE MICRO HEMATOCRIT TUBE READER, Substantially Equivalent on 1987-03-16. Applicant: Norfolk Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Norfolk Scientific, Inc.
Product code: Code JPI
Device class: Class 2
Regulation: 21 CFR 864.6400
Advisory panel: Hematology
Date received: 1987-02-05
Decision date: 1987-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwood, MA, US

Download summary PDF View on FDA.gov ↗

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