Radioimmunoassay, Glucagon
This device is a radioimmunoassay system used to measure glucagon concentrations in patient plasma, used in the evaluation of glucagonoma, diabetes mellitus, hypoglycemia, and other disorders involving abnormal glucagon secretion from pancreatic alpha cells. It is classified as FDA Class 1 and requires only general controls with no premarket submission. The product code is JME, regulated under 21 CFR 862.1335, and assigned to the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JME
- Device Class
- FDA class 1
- Regulation Number
- 862.1335
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K893975 | DOUBLE ANTIBODY GLUCAGON | Oct 31, 1989 | Substantially Equivalent | Diagnostic Products Corp. |
| K782143 | RIA KIT, GLUCOSE | Feb 22, 1979 | Substantially Equivalent | Serono Laboratories, Inc. |
| K771948 | GLUCAGON RIA MODULE | Jan 20, 1978 | Substantially Equivalent | Inter Science Institute |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.