CRIT-LINE HEMATOCRIT ALERT (MODIFICATION)— 510(k) K953875

Name: FDA 510(k) clearance K953875
Creator: U.S. Food and Drug Administration
Published: 1996-07-23

Substantially Equivalent

In-Line Diagnostics Corp.

FDA 510(k) clearance K953875 for CRIT-LINE HEMATOCRIT ALERT (MODIFICATION), Substantially Equivalent on 1996-07-23. Applicant: In-Line Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: In-Line Diagnostics Corp.
Product code: Code MQS
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1995-06-28
Decision date: 1996-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Riverdale, UT, US

Download summary PDF View on FDA.gov ↗

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