Product code JPH
- Device name
- Test, Erythrocyte 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 |
|---|---|---|---|
| K871076 | WINPETTE | Ulster Scientific, Inc. | 1987-03-23 |
| K860899 | DISPETTE II | Ulster Scientific, Inc. | 1986-04-14 |
| K852554 | SRT-SYSTEM | Microwave Development, Inc. | 1985-07-18 |
| K840500 | SEDIPLAST | Precision Technology, Inc. | 1984-02-21 |
| K831195 | WESTERGREN DISPETTE FOR ESR | Ulster Scientific, Inc. | 1983-05-09 |
| K823761 | ERYTHROCYTE & STAND SEDIMENT. RATE TUBE | Cordis Corp. | 1983-01-21 |
| K823368 | DADE ESR KIT | American Dade | 1982-12-28 |
Related GUDID Devices#
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|---|---|---|---|
| 10810160810411 | Red Tunica | Rodimedi & Associates, Inc. | 2025-03-14 |
| 00810160810414 | Red Tunica | Rodimedi & Associates, Inc. | 2025-03-14 |
| 00860011967712 | ZELLESR-10 | STERILE SAFEQUIP & CHEMICALS LLP | 2024-07-07 |
| 00840095682411 | Globe Scientific | GLOBE SCIENTIFIC INC. | 2023-07-05 |
| 00840095624565 | Globe Scientific | GLOBE SCIENTIFIC INC. | 2023-07-05 |
| 00840095682404 | Globe Scientific | GLOBE SCIENTIFIC INC. | 2023-07-05 |
| 00840095624572 | Globe Scientific | GLOBE SCIENTIFIC INC. | 2023-07-05 |
| 04038917085304 | ESR rack for S-Sedivette® | Sarstedt Aktiengesellschaft & Co.KG | 2022-11-30 |
| 04038917085205 | ESR rack for Monovette® | Sarstedt Aktiengesellschaft & Co.KG | 2022-11-30 |
| 04038917135047 | ESR pipette with graduation | Sarstedt Aktiengesellschaft & Co.KG | 2022-11-30 |
| 04038917088138 | ESR pipette without graduation | Sarstedt Aktiengesellschaft & Co.KG | 2022-11-30 |
| 04038917085311 | ESR rack for Microvette® | Sarstedt Aktiengesellschaft & Co.KG | 2022-11-30 |
| 04038917169943 | ESR pipette without graduation | Sarstedt Aktiengesellschaft & Co.KG | 2022-11-30 |
| 04038917207607 | ESR pipette with graduation | Sarstedt Aktiengesellschaft & Co.KG | 2022-11-30 |
| 08033891321017 | ESR Control | DIESSE DIAGNOSTICA SENESE SPA | 2022-11-25 |
| 08033891321048 | ESR Control | DIESSE DIAGNOSTICA SENESE SPA | 2022-11-25 |
| 08033891328207 | ESR Control Cube | DIESSE DIAGNOSTICA SENESE SPA | 2022-11-25 |
| 08033891328757 | ESR Control Cube | DIESSE DIAGNOSTICA SENESE SPA | 2022-11-25 |
| 29120017578189 | Vacuette | Greiner Bio-One GmbH | 2020-09-30 |
| 29120017578172 | Vacuette | Greiner Bio-One GmbH | 2020-09-30 |
| 29120017578158 | Vacuette | Greiner Bio-One GmbH | 2020-09-25 |
| 07612964013113 | DISPETTE® | Guest Scientific AG | 2020-06-01 |
| 07612964013106 | DISPETTE® | Guest Scientific AG | 2020-06-01 |
| 07612964013533 | DISPETTE® | Guest Scientific AG | 2019-11-07 |
| 07612964013403 | DISPETTE® | Guest Scientific AG | 2019-11-07 |
| 07612964013328 | DISPETTE® | Guest Scientific AG | 2019-11-07 |
| 07612964013304 | DISPETTE® | Guest Scientific AG | 2019-11-07 |
| 07612964000762 | DISPETTE® | Guest Scientific AG | 2019-11-07 |
| 20885380168557 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-06-07 |
| 20885380168540 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-06-07 |