Product code GHC
- Device name
- Tube, Sedimentation Rate
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.6700
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K885114 | SALMONELLA IFA* | Investigacion Farmaceutica S.A. DE C.V. | 1989-08-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08033891320522 | VACU-TEC | DIESSE DIAGNOSTICA SENESE SPA | 2024-01-22 |
| 08033891320645 | VACU-TEC CUVETTE-L | DIESSE DIAGNOSTICA SENESE SPA | 2024-01-22 |
| 08033891320690 | VES-TEC CUVETTE-L | DIESSE DIAGNOSTICA SENESE SPA | 2024-01-22 |
| 08033891321086 | VACU-TEC S.C. | DIESSE DIAGNOSTICA SENESE SPA | 2024-01-22 |
| 08033891321093 | VACU-TEC S.C. STERILE | DIESSE DIAGNOSTICA SENESE SPA | 2024-01-22 |
| 04038917127653 | Microvette® CB 200 NC | Sarstedt Aktiengesellschaft & Co.KG | 2022-11-30 |
| 04038917201360 | Microvette® CB 200 NC | Sarstedt Aktiengesellschaft & Co.KG | 2022-11-30 |
| 08033891320546 | VACU-TEC DOUBLE LABEL | DIESSE DIAGNOSTICA SENESE SPA | 2022-11-25 |
| 08033891320577 | VES-TEC | DIESSE DIAGNOSTICA SENESE SPA | 2022-11-25 |
| 00840095606028 | Globe Scientific | GLOBE SCIENTIFIC INC. | 2019-11-26 |
| 00840095606004 | Globe Scientific | GLOBE SCIENTIFIC INC. | 2019-11-26 |
| 00840095605984 | Globe Scientific | GLOBE SCIENTIFIC INC. | 2019-11-26 |
| 00840095605977 | Globe Scientific | GLOBE SCIENTIFIC INC. | 2019-11-26 |
| 00840095605960 | Globe Scientific | GLOBE SCIENTIFIC INC. | 2019-11-26 |
| 00840095605946 | Globe Scientific | GLOBE SCIENTIFIC INC. | 2019-11-26 |
| 00840095605939 | Globe Scientific | GLOBE SCIENTIFIC INC. | 2019-11-26 |
| 00840095606059 | Globe Scientific | GLOBE SCIENTIFIC INC. | 2019-11-26 |
| 03661540700613 | Excyte® | ELITechGroup B.V. | 2016-11-24 |
| 03661540700668 | Excyte® | ELITechGroup B.V. | 2016-11-24 |
| 03661540700675 | Excyte® | ELITechGroup B.V. | 2016-11-24 |
| 03661540700606 | Excyte® | ELITechGroup B.V. | 2016-11-24 |
| 29120017575263 | Vacuette | Greiner Bio-One GmbH | 2016-09-23 |
| 39120017575260 | Vacuette | Greiner Bio-One GmbH | 2016-09-23 |
| 00844509000006 | ESR-Vacuum tubes | STRECK, INC. | 2016-09-19 |
| 10844509000003 | ESR-Vacuum tubes | STRECK, INC. | 2016-09-19 |
| 00844509000020 | ESR-Vacuum tubes | STRECK, INC. | 2016-09-19 |
| 10844509000065 | ESR-Vacuum tubes | STRECK, INC. | 2016-09-19 |
| 10844509000041 | ESR-Vacuum tubes | STRECK, INC. | 2016-09-19 |
| 10844509000027 | ESR-Vacuum tubes | STRECK, INC. | 2016-09-19 |
| 04038917133128 | S-Sedivette® | Sarstedt Aktiengesellschaft & Co.KG | 2016-09-16 |