FDA product code GGP: Test, Qualitative And Quantitative Factor Deficiency
GGP is the FDA product code for test, qualitative and quantitative factor deficiency. It is a Class II device, regulated under 21 CFR 864.7290 and reviewed by the Hematology panel. FDA has cleared 190 510(k) submissions under GGP, 5 in the last five years, from 54 different applicants. The average 510(k) review took 108 days (median 71); 108 days on average over the last three years. FDA has posted 14 recalls for GGP devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Test, Qualitative And Quantitative Factor Deficiency |
| Device class | Class II |
| Regulation | 21 CFR 864.7290 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GGP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 88 |
| 2019 | 1 | 90 |
| 2020 | 2 | 232 |
| 2022 | 2 | 198 |
| 2023 | 2 | 352 |
| 2025 | 1 | 108 |
Compare with all 510(k) review times · Search every GGP clearance
Top GGP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Instrumentation Laboratory CO | 27 | 2022-12-09 |
| American Bioproducts Co. | 22 | 1997-08-19 |
| Helena Laboratories | 17 | 1996-02-09 |
| Biopool AB | 9 | 1995-09-25 |
| American Dade | 9 | 1987-02-10 |
49 more applicants have GGP clearances. See the full list in Caduvo.
Most recent GGP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251440 | Precision Biologic, Inc. | CRYOcheck Chromogenic Factor VIII | 2025-08-25 | 108 |
| K230852 | Instrumentation Laboratory Company | HemosIL Chromogenic Factor IX | 2023-12-13 | 260 |
| K220728 | Siemens Healthcare Diagnostics Products GmbH | vWF Ag | 2023-06-02 | 445 |
| K214002 | Precision Biologic, Inc. | CRYOcheck Chromogenic Factor IX | 2022-12-23 | 367 |
| K223402 | Instrumentation Laboratory CO | HemosIL von Willebrand Factor Antigen | 2022-12-09 | 30 |
Recalls for GGP devices
14 product recalls in 14 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2026-07-29.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2020 | 1 |
| 2023 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code GGP?
GGP is the FDA product code for test, qualitative and quantitative factor deficiency. It is a Class II device, regulated under 21 CFR 864.7290 and reviewed by the Hematology panel.
What device class is GGP?
Class II, regulation 21 CFR 864.7290. Typical premarket route: 510(k).
How long does a 510(k) take for product code GGP?
Across 190 cleared submissions the average was 108 days from receipt to decision (median 71).
Which companies have the most GGP clearances?
Instrumentation Laboratory CO (27); American Bioproducts Co. (22); Helena Laboratories (17); Biopool AB (9); American Dade (9).
Have GGP devices been recalled?
Yes: 14 product recalls across 14 recall events; the most recent began 2026-07-29.
Next steps
- Run an FDA pathway report with predicate devices for product code GGP
- Run a recall and safety report across every GGP manufacturer
- Watch product code GGP 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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