FDA product code GKF: Instrument, Hematocrit, Automated
GKF is the FDA product code for instrument, hematocrit, automated. It is a Class II device, regulated under 21 CFR 864.5600 and reviewed by the Hematology panel. FDA has cleared 15 510(k) submissions under GKF, from 12 different applicants. The average 510(k) review took 84 days (median 49). FDA has posted 1 recall for GKF devices.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Hematocrit, Automated |
| Device class | Class II |
| Regulation | 21 CFR 864.5600 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every GKF clearance
Top GKF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nova Biomedical Corp. | 3 | 1998-05-12 |
| Fisher Scientific Co., LLC | 2 | 1992-03-11 |
| Instrumentation Laboratory CO | 1 | 2016-12-14 |
| In-Line Diagnostics Corp. | 1 | 1999-05-27 |
| Vulcon Technologies | 1 | 1995-11-03 |
7 more applicants have GKF clearances. See the full list in Caduvo.
Most recent GKF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K160415 | Instrumentation Laboratory CO | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) | 2016-12-14 | 306 |
| K983551 | In-Line Diagnostics Corp. | CRIT-SCAN II MONITOR | 1999-05-27 | 230 |
| K981426 | Nova Biomedical Corp. | STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS | 1998-05-12 | 26 |
| K981425 | Nova Biomedical Corp. | STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS | 1998-05-12 | 26 |
| K981427 | Nova Biomedical Corp. | STAT PROFILE M ANALYZER | 1998-05-12 | 26 |
Recalls for GKF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-05-24.
Frequently asked questions
What is FDA product code GKF?
GKF is the FDA product code for instrument, hematocrit, automated. It is a Class II device, regulated under 21 CFR 864.5600 and reviewed by the Hematology panel.
What device class is GKF?
Class II, regulation 21 CFR 864.5600. Typical premarket route: 510(k).
How long does a 510(k) take for product code GKF?
Across 15 cleared submissions the average was 84 days from receipt to decision (median 49).
Which companies have the most GKF clearances?
Nova Biomedical Corp. (3); Fisher Scientific Co., LLC (2); Instrumentation Laboratory CO (1); In-Line Diagnostics Corp. (1); Vulcon Technologies (1).
Have GKF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2005-05-24.
Next steps
- Run an FDA pathway report with predicate devices for product code GKF
- Run a recall and safety report across every GKF manufacturer
- Watch product code GKF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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