Test, Erythrocyte Sedimentation Rate
The Test, Erythrocyte Sedimentation Rate is a hematology diagnostic device used to measure the rate at which red blood cells settle in a vertical column of anticoagulated blood over one hour, a nonspecific marker of systemic inflammation used to screen for and monitor inflammatory, infectious, and neoplastic conditions. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket notification required. It carries product code JPH and is regulated under 21 CFR 864.6700, within the Hematology medical specialty.
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Basic Information
- Product Code
- JPH
- Device Class
- FDA class 1
- Regulation Number
- 864.6700
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K871076 | WINPETTE | Mar 23, 1987 | Substantially Equivalent | Ulster Scientific, Inc. |
| K860899 | DISPETTE II | Apr 14, 1986 | Substantially Equivalent | Ulster Scientific, Inc. |
| K852554 | SRT-SYSTEM | Jul 18, 1985 | Substantially Equivalent | Microwave Development, Inc. |
| K840500 | SEDIPLAST | Feb 21, 1984 | Substantially Equivalent | Precision Technology, Inc. |
| K831195 | WESTERGREN DISPETTE FOR ESR | May 09, 1983 | Substantially Equivalent | Ulster Scientific, Inc. |
| K823761 | ERYTHROCYTE & STAND SEDIMENT. RATE TUBE | Jan 21, 1983 | Substantially Equivalent | Cordis Corp. |
| K823368 | DADE ESR KIT | Dec 28, 1982 | Substantially Equivalent | American Dade |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.