JPH — Test, Erythrocyte Sedimentation Rate Class I
FDA product code JPH covers "Test, Erythrocyte Sedimentation Rate", a Class I medical device regulated under 21 CFR 864.6700. Submissions are reviewed by the Hematology panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JPH
- Device Class
- Class I
- Regulation Number
- 864.6700
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K871076 | Ulster Scientific | WINPETTE | Mar 23, 1987 |
| K860899 | Ulster Scientific | DISPETTE II | Apr 14, 1986 |
| K852554 | Microwave Development | SRT-SYSTEM | Jul 18, 1985 |
| K840500 | Precision Technology | SEDIPLAST | Feb 21, 1984 |
| K831195 | Ulster Scientific | WESTERGREN DISPETTE FOR ESR | May 9, 1983 |
| K823761 | Cordis | ERYTHROCYTE & STAND SEDIMENT. RATE TUBE | Jan 21, 1983 |
| K823368 | American Dade | DADE ESR KIT | Dec 28, 1982 |