FDA product code GGN: Plasma, Coagulation Control
GGN is the FDA product code for plasma, coagulation control. It is a Class II device, regulated under 21 CFR 864.5425 and reviewed by the Hematology panel. FDA has cleared 99 510(k) submissions under GGN, from 40 different applicants. The average 510(k) review took 127 days (median 75). FDA has posted 16 recalls for GGN devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Plasma, Coagulation Control |
| Device class | Class II |
| Regulation | 21 CFR 864.5425 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for GGN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 142 |
Compare with all 510(k) review times · Search every GGN clearance
Top GGN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Instrumentation Laboratory CO | 7 | 2012-01-04 |
| Bio-Rad | 7 | 2004-02-27 |
| Helena Laboratories | 7 | 1996-03-11 |
| Precision Biologicals, Inc. | 6 | 1997-08-29 |
| Pacific Hemostasis | 5 | 2000-03-24 |
35 more applicants have GGN clearances. See the full list in Caduvo.
Most recent GGN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K170864 | Maine Standards Company, LLC | VALIDATE D-Dimer Calibration Verification / Linearity Test Kit | 2017-06-21 | 90 |
| K163498 | Maine Standards Company, LLC | VALIDATE Heparin Calibration Verification/Linearity Test Kit | 2017-03-16 | 93 |
| K161316 | George King Bio-Medical, Inc. | George King Coumadin Plasma | 2017-02-23 | 288 |
| K162705 | Maine Standards Company, LLC | VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit | 2017-01-05 | 99 |
| K152961 | Maine Standards Company, LLC | VALIDATE D-Dimer Calibration Verification/Linearity Test Kit | 2016-06-03 | 240 |
Recalls for GGN devices
16 product recalls in 11 recall events; 3 initiated in the last five years and 2 still open. Most recent: 2026-07-01.
| Year | Recalls |
|---|---|
| 2019 | 4 |
| 2022 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code GGN?
GGN is the FDA product code for plasma, coagulation control. It is a Class II device, regulated under 21 CFR 864.5425 and reviewed by the Hematology panel.
What device class is GGN?
Class II, regulation 21 CFR 864.5425. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GGN?
Across 99 cleared submissions the average was 127 days from receipt to decision (median 75).
Which companies have the most GGN clearances?
Instrumentation Laboratory CO (7); Bio-Rad (7); Helena Laboratories (7); Precision Biologicals, Inc. (6); Pacific Hemostasis (5).
Have GGN devices been recalled?
Yes: 16 product recalls across 11 recall events; the most recent began 2026-07-01.
Next steps
- Run an FDA pathway report with predicate devices for product code GGN
- Run a recall and safety report across every GGN manufacturer
- Watch product code GGN 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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