CRIT-LINE HEMATOCRIT ALERT— 510(k) K950942

Name: FDA 510(k) clearance K950942
Creator: U.S. Food and Drug Administration
Published: 1995-03-14

Substantially Equivalent

In-Line Diagnostics Corp.

FDA 510(k) clearance K950942 for CRIT-LINE HEMATOCRIT ALERT, Substantially Equivalent on 1995-03-14. Applicant: In-Line Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: In-Line Diagnostics Corp.
Product code: Code JPI
Device class: Class 2
Regulation: 21 CFR 864.6400
Advisory panel: Hematology
Date received: 1995-02-15
Decision date: 1995-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Riverdale, UT, US

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