FDA product code GLK: Control, Hematocrit
GLK is the FDA product code for control, hematocrit. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel. FDA has cleared 7 510(k) submissions under GLK, from 7 different applicants. The average 510(k) review took 114 days (median 78).
Classification
| Field | Value |
|---|---|
| Device name | Control, Hematocrit |
| Device class | Class II |
| Regulation | 21 CFR 864.8625 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GLK clearance
Top GLK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eurotrol B.V. | 1 | 2013-05-10 |
| Bionostics, Inc. | 1 | 2002-06-24 |
| Aalto Scientific, Ltd. | 1 | 2002-05-14 |
| Richmond Diagnostics, Inc. | 1 | 1997-02-20 |
| Ciba Corning Diagnostics Corp. | 1 | 1996-07-26 |
2 more applicants have GLK clearances. See the full list in Caduvo.
Most recent GLK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K121467 | Eurotrol B.V. | EUROTROL HEMATOCRIT CONTROL | 2013-05-10 | 358 |
| K021924 | Bionostics, Inc. | MEDICA EASYQC HEMATOCRIT CONTROL | 2002-06-24 | 13 |
| K020618 | Aalto Scientific, Ltd. | AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL | 2002-05-14 | 78 |
| K964452 | Richmond Diagnostics, Inc. | HEMATACHEK | 1997-02-20 | 106 |
| K961807 | Ciba Corning Diagnostics Corp. | CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 | 1996-07-26 | 77 |
Recalls for GLK devices
openFDA lists no recalls for product code GLK.
Frequently asked questions
What is FDA product code GLK?
GLK is the FDA product code for control, hematocrit. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel.
What device class is GLK?
Class II, regulation 21 CFR 864.8625. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GLK?
Across 7 cleared submissions the average was 114 days from receipt to decision (median 78).
Which companies have the most GLK clearances?
Eurotrol B.V. (1); Bionostics, Inc. (1); Aalto Scientific, Ltd. (1); Richmond Diagnostics, Inc. (1); Ciba Corning Diagnostics Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GLK
- Run a recall and safety report across every GLK manufacturer
- Watch product code GLK 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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