Instrument, Hematocrit, Automated
Instrument, Hematocrit, Automated (product code GKF) is an automated device used to measure the hematocrit, or packed red cell volume, without the need for manual centrifugation, providing a rapid and reproducible determination of the proportion of blood volume occupied by red blood cells. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.5600 in the Hematology specialty (HE), this device carries no special regulatory flags.
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Basic Information
- Product Code
- GKF
- Device Class
- FDA class 2
- Regulation Number
- 864.5600
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K160415 | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) | Dec 14, 2016 | Substantially Equivalent | Instrumentation Laboratory CO |
| K983551 | CRIT-SCAN II MONITOR | May 27, 1999 | Substantially Equivalent | In-Line Diagnostics Corp. |
| K981427 | STAT PROFILE M ANALYZER | May 12, 1998 | Substantially Equivalent | Nova Biomedical Corp. |
| K981426 | STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS | May 12, 1998 | Substantially Equivalent | Nova Biomedical Corp. |
| K981425 | STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS | May 12, 1998 | Substantially Equivalent | Nova Biomedical Corp. |
| K953519 | MICROSPIN 24 | Nov 03, 1995 | Substantially Equivalent | Vulcon Technologies |
| K915825 | MARATHON 6K GENERAL-PURPOSE CENTRIFUGE | Mar 11, 1992 | Substantially Equivalent | Fisher Scientific Co., LLC |
| K915441 | MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE | Jan 08, 1992 | Substantially Equivalent | Fisher Scientific Co., LLC |
| K904336 | NEW COBE SATURATION/HEMATOCRIT MONITOR | Dec 27, 1990 | Substantially Equivalent | Cobe Laboratories, Inc. |
| K880373 | IONOMETER E-HK AND ACCESSORIES | Mar 17, 1988 | Substantially Equivalent | Smash Ent., Inc. |
| K870860 | CHEMPRO 1000(TM) | Apr 14, 1987 | Substantially Equivalent | Arden Medical Systems, Inc. |
| K864646 | SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE | Jan 05, 1987 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
| K864039 | MICROHEMATOCRIT CENTRIFUGE | Oct 29, 1986 | Substantially Equivalent | Plaza Medical, Inc. |
| K802199 | STAT-CRIT HEMATOCRIT MEASURING INSTRU | Feb 04, 1981 | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc |
| K781059 | CUTTER/COMPUR MINI CENTRIFUGE | Aug 14, 1978 | Substantially Equivalent | Cutter Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.