GKF · Instrument, Hematocrit, Automated
Hematology · 21 CFR 864.5600 · Class 2
Overview
| Product Code | GKF |
|---|---|
| Device Name | Instrument, Hematocrit, Automated |
| Regulation | 21 CFR 864.5600 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
An automated hematocrit instrument is a fully automated or semi-automated device which may or may not be part of a larger system. This device measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K160415 | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) | Instrumentation Laboratory CO | Dec 14, 2016 | SESE |
| K983551 | CRIT-SCAN II MONITOR | In-Line Diagnostics Corp. | May 27, 1999 | SESE |
| K981427 | STAT PROFILE M ANALYZER | Nova Biomedical Corp. | May 12, 1998 | SESE |
| K981426 | STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS | Nova Biomedical Corp. | May 12, 1998 | SESE |
| K981425 | STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS | Nova Biomedical Corp. | May 12, 1998 | SESE |
| K953519 | MICROSPIN 24 | Vulcon Technologies | Nov 3, 1995 | SESE |
| K915825 | MARATHON 6K GENERAL-PURPOSE CENTRIFUGE | Fisher Scientific Co., LLC | Mar 11, 1992 | SESE |
| K915441 | MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE | Fisher Scientific Co., LLC | Jan 8, 1992 | SESE |
| K904336 | NEW COBE SATURATION/HEMATOCRIT MONITOR | Cobe Laboratories, Inc. | Dec 27, 1990 | SESE |
| K880373 | IONOMETER E-HK AND ACCESSORIES | Smash Ent., Inc. | Mar 17, 1988 | SESE |
| K870860 | CHEMPRO 1000(TM) | Arden Medical Systems, Inc. | Apr 14, 1987 | SESE |
| K864646 | SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE | E.I. Dupont DE Nemours & Co., Inc. | Jan 5, 1987 | SESE |
| K864039 | MICROHEMATOCRIT CENTRIFUGE | Plaza Medical, Inc. | Oct 29, 1986 | SESE |
| K802199 | STAT-CRIT HEMATOCRIT MEASURING INSTRU | United States Surgical, A Division of Tyco Healthc | Feb 4, 1981 | SESE |
| K781059 | CUTTER/COMPUR MINI CENTRIFUGE | Cutter Laboratories, Inc. | Aug 14, 1978 | SESE |
Top Applicants
- Nova Biomedical Corp. — 3 clearances
- Fisher Scientific Co., LLC — 2 clearances
- Arden Medical Systems, Inc. — 1 clearance
- Cobe Laboratories, Inc. — 1 clearance
- Cutter Laboratories, Inc. — 1 clearance
