FDA product code GGW: Test, Time, Partial Thromboplastin
GGW is the FDA product code for test, time, partial thromboplastin. It is a Class II device, regulated under 21 CFR 864.7925 and reviewed by the Hematology panel. FDA has cleared 32 510(k) submissions under GGW, 1 in the last five years, from 23 different applicants. The average 510(k) review took 117 days (median 81); 30 days on average over the last three years. FDA has posted 4 recalls for GGW devices.
Classification
| Field | Value |
|---|---|
| Device name | Test, Time, Partial Thromboplastin |
| Device class | Class II |
| Regulation | 21 CFR 864.7925 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GGW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 30 |
Compare with all 510(k) review times · Search every GGW clearance
Top GGW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Bioproducts Co. | 4 | 1995-03-21 |
| Bio/Data Corp. | 3 | 1987-11-20 |
| Helena Laboratories | 3 | 1983-04-05 |
| R2 Diagnostics, Inc. | 2 | 2010-12-30 |
| American Dade | 2 | 1986-10-17 |
18 more applicants have GGW clearances. See the full list in Caduvo.
Most recent GGW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260551 | Instrumentation Laboratory (IL) Co. | HemosIL Factor V Leiden (APC Resistance V) | 2026-03-20 | 30 |
| K090105 | R2 Diagnostics, Inc. | LUPOTEK KCT | 2010-12-30 | 714 |
| K083729 | Aniara Diagnostica, LLC | HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN | 2009-05-08 | 143 |
| K060284 | Precision Biologic, Inc. | CRYOCHECK CLOT APCR | 2006-05-10 | 96 |
| K042762 | Pentapharm , Ltd. | PEFAKIT APC-R FACTOR V LEIDEN | 2004-12-22 | 78 |
Recalls for GGW devices
4 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-03-11.
Frequently asked questions
What is FDA product code GGW?
GGW is the FDA product code for test, time, partial thromboplastin. It is a Class II device, regulated under 21 CFR 864.7925 and reviewed by the Hematology panel.
What device class is GGW?
Class II, regulation 21 CFR 864.7925. Typical premarket route: 510(k).
How long does a 510(k) take for product code GGW?
Across 32 cleared submissions the average was 117 days from receipt to decision (median 81).
Which companies have the most GGW clearances?
American Bioproducts Co. (4); Bio/Data Corp. (3); Helena Laboratories (3); R2 Diagnostics, Inc. (2); American Dade (2).
Have GGW devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2013-03-11.
Next steps
- Run an FDA pathway report with predicate devices for product code GGW
- Run a recall and safety report across every GGW manufacturer
- Watch product code GGW 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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