FDA product code GHH: Fibrin Split Products
GHH is the FDA product code for fibrin split products. It is a Class II device, regulated under 21 CFR 864.7320 and reviewed by the Hematology panel. FDA has cleared 28 510(k) submissions under GHH, from 20 different applicants. The average 510(k) review took 154 days (median 90). FDA has posted 9 recalls for GHH devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Fibrin Split Products |
| Device class | Class II |
| Regulation | 21 CFR 864.7320 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GHH clearance
Top GHH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostics Corp. | 3 | 2007-03-14 |
| Agen Biomedical , Ltd. | 3 | 1999-12-14 |
| American Bioproducts Co. | 3 | 1989-02-07 |
| Abbott Laboratories | 2 | 1989-08-03 |
| E.I. Dupont DE Nemours & Co., Inc. | 2 | 1985-10-04 |
15 more applicants have GHH clearances. See the full list in Caduvo.
Most recent GHH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K112120 | Diazyme Laboratories | DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET | 2013-01-24 | 549 |
| K072288 | Mitsubishi Kagaku Iatron | PATHFAST D-DIMER | 2009-05-06 | 629 |
| K070453 | Olympus Life & Material Science Europa GmbH (Irish | OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL | 2007-06-11 | 115 |
| K062203 | Roche Diagnostics Corp. | TINA-QUANT D-DIMER TEST SYSTEM | 2007-03-14 | 225 |
| K042890 | Biosite Incorporated | TRIAGE D-DIMER TEST, MODEL 98100 | 2004-11-29 | 41 |
Recalls for GHH devices
9 product recalls in 9 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-10-03.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code GHH?
GHH is the FDA product code for fibrin split products. It is a Class II device, regulated under 21 CFR 864.7320 and reviewed by the Hematology panel.
What device class is GHH?
Class II, regulation 21 CFR 864.7320. Typical premarket route: 510(k).
How long does a 510(k) take for product code GHH?
Across 28 cleared submissions the average was 154 days from receipt to decision (median 90).
Which companies have the most GHH clearances?
Roche Diagnostics Corp. (3); Agen Biomedical , Ltd. (3); American Bioproducts Co. (3); Abbott Laboratories (2); E.I. Dupont DE Nemours & Co., Inc. (2).
Have GHH devices been recalled?
Yes: 9 product recalls across 9 recall events; the most recent began 2023-10-03.
Next steps
- Run an FDA pathway report with predicate devices for product code GHH
- Run a recall and safety report across every GHH manufacturer
- Watch product code GHH 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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