Cleared Traditional

CRIT-LINE

K924167 · Noninvasive Medical Technology Corp. · Hematology

May 1993

Decision

261d

Days

Class 2

Risk

About This 510(k) Submission

K924167 is an FDA 510(k) clearance for the CRIT-LINE, a Device, Hematocrit Measuring (Class II — Special Controls, product code JPI), submitted by Noninvasive Medical Technology Corp. (Ogden, US). The FDA issued a Cleared decision on May 7, 1993, 261 days after receiving the submission on August 19, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6400.

Submission Details

510(k) Number	K924167 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 1992
Decision Date	May 07, 1993
Days to Decision	261 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement