Cell Enzymes (Erythrocytic And Leukocytic)
Erythrocytic and leukocytic cell enzyme reagents and test systems are laboratory devices used to measure the activity of specific enzymes within red blood cells and white blood cells, supporting the diagnosis of hereditary enzyme deficiency disorders and certain hematological malignancies. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JBE, regulated under 21 CFR 864.7100, within the Hematology medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- JBE
- Device Class
- FDA class 2
- Regulation Number
- 864.7100
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
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 |
|---|---|---|---|---|
| K822733 | SIGMA REAGENT SYSTEM NO. 885 | Dec 03, 1982 | Substantially Equivalent | Sigma Chemical Co. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.