CRIT-LINE— 510(k) K924167

Substantially Equivalent

Noninvasive Medical Technology Corp.

FDA 510(k) clearance K924167 for CRIT-LINE, Substantially Equivalent on 1993-05-07. Applicant: Noninvasive Medical Technology Corp.. Device class: 2.

Clearance details

Applicant: Noninvasive Medical Technology Corp.
Product code: Code JPI
Device class: Class 2
Regulation: 21 CFR 864.6400
Advisory panel: Hematology
Date received: 1992-08-19
Decision date: 1993-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ogden, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JPI

K183680 — i-STAT CHEM8+ cartridge with the i-STAT 1 System2020-02-28
K163342 — i-STAT Hematocrit test with i-STAT Alinity System2017-08-22
K950942 — CRIT-LINE HEMATOCRIT ALERT1995-03-14
K903698 — STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES1990-09-17
K902028 — STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER1990-06-20

More clearances from Noninvasive Medical Technology Corp.

K910077 — CRIT-SCAN1992-06-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.