Cleared Traditional

CRIT-LINE HEMATOCRIT ALERT (MODIFICATION)

K953875 · In-Line Diagnostics Corp. · Gastroenterology & Urology

Jul 1996

Decision

391d

Days

Class 2

Risk

About This 510(k) Submission

K953875 is an FDA 510(k) clearance for the CRIT-LINE HEMATOCRIT ALERT (MODIFICATION), a System, Hemodialysis, Access Recirculation Monitoring (Class II — Special Controls, product code MQS), submitted by In-Line Diagnostics Corp. (Riverdale, US). The FDA issued a Cleared decision on July 23, 1996, 391 days after receiving the submission on June 28, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number	K953875 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 1995
Decision Date	July 23, 1996
Days to Decision	391 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement