GGWClass II
Test, Time, Partial Thromboplastin
21 CFR 864.7925 / Hematology
GGW is the FDA product code for Test, Time, Partial Thromboplastin, a class II device type, regulated under 21 CFR 864.7925. As of , FDA records hold 32 510(k) clearances under this code, the most recent dated , and 4 recalls.
Classification record
- Product code
- GGW
- Device name
- Test, Time, Partial Thromboplastin
- Regulation
- 21 CFR 864.7925
- Device class
- Class II
- Review panel
- Hematology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 32
- Ingested recalls
- 4
Clearances, product code GGW
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1980 | 6 |
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 3 |
| 1986 | 2 |
| 1987 | 1 |
| 1990 | 1 |
| 1992 | 2 |
| 1993 | 1 |
| 1995 | 2 |
| 1996 | 1 |
| 1999 | 2 |
| 2004 | 2 |
| 2006 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code GGW| Applicant | Clearances |
|---|---|
| American Bioproducts Co. | 4 |
| Bio/Data Corp. | 3 |
| Helena Laboratories, Corp. | 3 |
| American Dade | 2 |
| R2 Diagnostics, Inc. | 2 |
| Abbott Medical | 1 |
| Aniara Diagnostica LLC | 1 |
| Axis-Shield Doc AS | 1 |
| Biosearch Medical Products, Inc. | 1 |
| Chromogenix AB | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.