FDA product code GGM: Control, Hemoglobin
GGM is the FDA product code for control, hemoglobin. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel. FDA has cleared 15 510(k) submissions under GGM, from 10 different applicants. The average 510(k) review took 60 days (median 43). FDA has posted 2 recalls for GGM devices.
Classification
| Field | Value |
|---|---|
| Device name | Control, Hemoglobin |
| Device class | Class II |
| Regulation | 21 CFR 864.8625 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for GGM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 84 |
Compare with all 510(k) review times · Search every GGM clearance
Top GGM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| R&D Systems, Inc. | 3 | 2007-03-29 |
| Eurotrol B.V. | 2 | 2019-11-15 |
| Bio-Rad | 2 | 2005-11-09 |
| Direct Solutions | 2 | 1996-11-06 |
| Bio-Rad Laboratories | 1 | 2007-04-02 |
5 more applicants have GGM clearances. See the full list in Caduvo.
Most recent GGM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192842 | Eurotrol B.V. | HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High | 2019-11-15 | 43 |
| K182744 | Eurotrol B.V. | HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High | 2019-02-01 | 126 |
| K070546 | Bio-Rad Laboratories | LYPHOCHEK DIABETES CONTROL | 2007-04-02 | 35 |
| K070334 | R&D Systems, Inc. | R&D SICKLE QC CONTROL | 2007-03-29 | 52 |
| K052838 | Bio-Rad | LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 | 2005-11-09 | 33 |
Recalls for GGM devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-10-18.
| Year | Recalls |
|---|---|
| 2018 | 2 |
Frequently asked questions
What is FDA product code GGM?
GGM is the FDA product code for control, hemoglobin. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel.
What device class is GGM?
Class II, regulation 21 CFR 864.8625. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GGM?
Across 15 cleared submissions the average was 60 days from receipt to decision (median 43).
Which companies have the most GGM clearances?
R&D Systems, Inc. (3); Eurotrol B.V. (2); Bio-Rad (2); Direct Solutions (2); Bio-Rad Laboratories (1).
Have GGM devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2018-10-18.
Next steps
- Run an FDA pathway report with predicate devices for product code GGM
- Run a recall and safety report across every GGM manufacturer
- Watch product code GGM 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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