FDA product code GKG: Centrifuge, Hematocrit
GKG is the FDA product code for centrifuge, hematocrit. It is a Class II device, regulated under 21 CFR 864.6400 and reviewed by the Hematology panel. FDA has cleared 11 510(k) submissions under GKG, from 9 different applicants. The average 510(k) review took 86 days (median 78). FDA has posted 4 recalls for GKG devices.
Classification
| Field | Value |
|---|---|
| Device name | Centrifuge, Hematocrit |
| Device class | Class II |
| Regulation | 21 CFR 864.6400 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GKG clearance
Top GKG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Separation Technology, Inc. | 2 | 1991-09-23 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 1982-09-14 |
| Micro Diagnostics Corp. | 1 | 1996-07-05 |
| Novonx, Inc. | 1 | 1996-03-29 |
| Fisher Scientific Co., LLC | 1 | 1993-03-23 |
4 more applicants have GKG clearances. See the full list in Caduvo.
Most recent GKG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K961803 | Micro Diagnostics Corp. | SPUNCRIT (MODEL DRC-40) | 1996-07-05 | 57 |
| K955795 | Novonx, Inc. | MULTI-CENTRIFUGE | 1996-03-29 | 98 |
| K930415 | Fisher Scientific Co., LLC | MICROHEMATOCRIT ROTOR | 1993-03-23 | 56 |
| K925863 | bioMerieux, Inc. | SPUNCRIT | 1993-02-05 | 78 |
| K920207 | Labnet Intl., Inc. | HERMLE Z230H | 1992-06-09 | 145 |
Recalls for GKG devices
4 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-11-21.
Frequently asked questions
What is FDA product code GKG?
GKG is the FDA product code for centrifuge, hematocrit. It is a Class II device, regulated under 21 CFR 864.6400 and reviewed by the Hematology panel.
What device class is GKG?
Class II, regulation 21 CFR 864.6400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GKG?
Across 11 cleared submissions the average was 86 days from receipt to decision (median 78).
Which companies have the most GKG clearances?
Separation Technology, Inc. (2); Bd Becton Dickinson Vacutainer Systems Preanalytic (2); Micro Diagnostics Corp. (1); Novonx, Inc. (1); Fisher Scientific Co., LLC (1).
Have GKG devices been recalled?
Yes: 4 product recalls across 1 recall events; the most recent began 2009-11-21.
Next steps
- Run an FDA pathway report with predicate devices for product code GKG
- Run a recall and safety report across every GKG manufacturer
- Watch product code GKG 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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