Densitometeric, Protein Fractionation
The Densitometric, Protein Fractionation device is a clinical chemistry instrument that uses densitometric scanning of electrophoresis gels or membranes to quantify protein fractions separated from serum or other biological specimens, used in the detection and monitoring of paraproteinemias, immunoglobulin deficiencies, and other protein abnormalities. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JQJ and is regulated under 21 CFR 862.1630, within the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JQJ
- Device Class
- FDA class 1
- Regulation Number
- 862.1630
- 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 |
|---|---|---|---|---|
| K901463 | REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO) | Jun 12, 1990 | Substantially Equivalent | Helena Laboratories |
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.