Plasma Viscometer For Clinical Use
This device is a plasma viscometer used in clinical laboratory settings to measure the viscosity of plasma, which can be elevated in conditions such as multiple myeloma, macroglobulinemia, and other hyperviscosity syndromes where abnormal protein accumulation affects blood flow properties. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is JJL, regulated under 21 CFR 862.2920, and assigned to the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JJL
- Device Class
- FDA class 1
- Regulation Number
- 862.2920
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K883503 | COULTER VISCOMETER II | Sep 19, 1988 | Substantially Equivalent | Coulter Electronics, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.