Cleared Traditional

CRIT-SCAN II MONITOR

K983551 · In-Line Diagnostics Corp. · Hematology
May 1999
Decision
230d
Days
Class 2
Risk

About This 510(k) Submission

K983551 is an FDA 510(k) clearance for the CRIT-SCAN II MONITOR, a Instrument, Hematocrit, Automated (Class II — Special Controls, product code GKF), submitted by In-Line Diagnostics Corp. (Farmington, US). The FDA issued a Cleared decision on May 27, 1999, 230 days after receiving the submission on October 9, 1998. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5600.

Submission Details

510(k) Number K983551 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 1998
Decision Date May 27, 1999
Days to Decision 230 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKF — Instrument, Hematocrit, Automated
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5600

Similar Devices — GKF Instrument, Hematocrit, Automated

All 14
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
K160415 · Instrumentation Laboratory CO · Dec 2016
STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS
K981425 · Nova Biomedical Corp. · May 1998
STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS
K981426 · Nova Biomedical Corp. · May 1998
STAT PROFILE M ANALYZER
K981427 · Nova Biomedical Corp. · May 1998
MICROSPIN 24
K953519 · Vulcon Technologies · Nov 1995
MARATHON 6K GENERAL-PURPOSE CENTRIFUGE
K915825 · Fisher Scientific Co., LLC · Mar 1992