Product code GKB
- Device name
- Device, Automated Sedimentation Rate
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.5800
- 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#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08719189137781 | Starrsed | Mechatronics USA LLC | 2024-08-26 |
| 00860011967736 | ZBT-ESR | STERILE SAFEQUIP & CHEMICALS LLP | 2024-07-09 |
| 00868556000208 | ESR STAT 6 | Airscan, Inc. | 2024-06-04 |
| 08033891324551 | VES-MATIC ORIGINAL | DIESSE DIAGNOSTICA SENESE SPA | 2023-12-14 |
| 00850028040041 | iSED Elite | ALCOR SCIENTIFIC INC. | 2023-11-03 |
| 03661540300271 | Excyte® ESR Vacuum Tube | ELITECHGROUP INC. | 2023-10-01 |
| 03661540300264 | Excyte® ESR Vacuum Tube | ELITECHGROUP INC. | 2023-10-01 |
| 03661540300257 | Excyte® ESR Vacuum Tubes | ELITECHGROUP INC. | 2023-10-01 |
| 03661540300240 | Excyte® ESR Non-Vacuum Tubes | ELITECHGROUP INC. | 2023-10-01 |
| 03661540300219 | Monosed® ESR Vacuum Tubes, Carton | ELITECHGROUP INC. | 2023-10-01 |
| 03661540300202 | Monosed® ESR Vacuum Tubes | ELITECHGROUP INC. | 2023-10-01 |
| 03661540300042 | Mix-Rate® X20 Automated ESR Analyzer | ELITECHGROUP INC. | 2023-10-01 |
| 03661540300035 | Microsed-System® Automated ESR Analyzer | ELITECHGROUP INC. | 2023-10-01 |
| 03661540300332 | Excyte® ESR Vacuum Tube, Carton | ELITECHGROUP INC. | 2023-10-01 |
| 03661540300325 | Excyte® ESR Vacuum Tube, Carton | ELITECHGROUP INC. | 2023-10-01 |
| 03661540300318 | Excyte® ESR Vacuum Tubes, Carton | ELITECHGROUP INC. | 2023-10-01 |
| 03661540300301 | Excyte® ESR Non-Vacuum Tubes, Carton | ELITECHGROUP INC. | 2023-10-01 |
| 03661540300295 | Monosed® ESR Vacuum Tubes, Carton | ELITECHGROUP INC. | 2023-10-01 |
| 03661540300288 | Monosed® ESR Vacuum Tubes, Carton | ELITECHGROUP INC. | 2023-10-01 |
| 08719189137132 | Starrsed Cleaning Agent | RR Mechatronics Manufacturing B.V. | 2023-07-25 |
| 08719189137217 | Starrsed Rinse Solution | RR Mechatronics Manufacturing B.V. | 2023-07-25 |
| 08719189137224 | Starrsed X-Clean | RR Mechatronics Manufacturing B.V. | 2023-07-25 |
| 08719189137231 | Starrsed Disinfectant | RR Mechatronics Manufacturing B.V. | 2023-07-25 |
| 08719189137200 | Starrsed Saline | RR Mechatronics Manufacturing B.V. | 2023-07-24 |
| 06936895301097 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-05 |
| 08719189137149 | Starrsed Control | RR Mechatronics Manufacturing B.V. | 2022-12-05 |
| 08719189137118 | Starrsed Control | RR Mechatronics Manufacturing B.V. | 2022-12-05 |
| 08719189137170 | Starrsed Control | RR Mechatronics Manufacturing B.V. | 2022-12-05 |
| 08719189137125 | Starrsed Control | RR Mechatronics Manufacturing B.V. | 2022-12-05 |
| 00858092006215 | QBC Diagnostics | DRUCKER DIAGNOSTICS | 2016-09-24 |