Cleared Traditional

CRIT-LINE HEMATOCRIT ALERT

K950942 · In-Line Diagnostics Corp. · Hematology
Mar 1995
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K950942 is an FDA 510(k) clearance for the CRIT-LINE HEMATOCRIT ALERT, a Device, Hematocrit Measuring (Class II — Special Controls, product code JPI), submitted by In-Line Diagnostics Corp. (Riverdale, US). The FDA issued a Cleared decision on March 14, 1995, 27 days after receiving the submission on February 15, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6400.

Submission Details

510(k) Number K950942 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 1995
Decision Date March 14, 1995
Days to Decision 27 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JPI — Device, Hematocrit Measuring
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.6400

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