FDA product code GKJ: Spinner, Slide, Automated
GKJ is the FDA product code for spinner, slide, automated. It is a Class I device, regulated under 21 CFR 864.5850 and reviewed by the Hematology panel. FDA has cleared 6 510(k) submissions under GKJ, from 5 different applicants. The average 510(k) review took 40 days (median 26). FDA has posted 1 recall for GKJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Spinner, Slide, Automated |
| Device class | Class I |
| Regulation | 21 CFR 864.5850 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GKJ clearance
Top GKJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Geometric Data, Div. Smithkline Corp. | 2 | 1981-08-18 |
| Ulster Scientific, Inc. | 1 | 1985-12-23 |
| Prevo Micro-Mat System | 1 | 1985-10-31 |
| Coulter Electronics, Inc. | 1 | 1983-06-16 |
| Dynatech Cryomedical Co. | 1 | 1977-10-18 |
Most recent GKJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K854962 | Ulster Scientific, Inc. | MICRO-MAT SYSTEM | 1985-12-23 | 12 |
| K854121 | Prevo Micro-Mat System | MICRO-MAT SYSTEM | 1985-10-31 | 22 |
| K831558 | Coulter Electronics, Inc. | E-Z PREP | 1983-06-16 | 31 |
| K811534 | Geometric Data, Div. Smithkline Corp. | HEMASPINNER | 1981-08-18 | 78 |
| K771898 | Dynatech Cryomedical Co. | AUTOMATED SLIDE SPINNER | 1977-10-18 | 12 |
Recalls for GKJ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-12-15.
Frequently asked questions
What is FDA product code GKJ?
GKJ is the FDA product code for spinner, slide, automated. It is a Class I device, regulated under 21 CFR 864.5850 and reviewed by the Hematology panel.
What device class is GKJ?
Class I, regulation 21 CFR 864.5850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GKJ?
Across 6 cleared submissions the average was 40 days from receipt to decision (median 26).
Which companies have the most GKJ clearances?
Geometric Data, Div. Smithkline Corp. (2); Ulster Scientific, Inc. (1); Prevo Micro-Mat System (1); Coulter Electronics, Inc. (1); Dynatech Cryomedical Co. (1).
Have GKJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2005-12-15.
Next steps
- Run an FDA pathway report with predicate devices for product code GKJ
- Run a recall and safety report across every GKJ manufacturer
- Watch product code GKJ 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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