Fluorometric Measurement, Porphyrins
This device is a fluorometric reagent system used in clinical chemistry to measure porphyrins in biological specimens such as urine, feces, or blood, supporting diagnosis of porphyrias, lead poisoning, and other conditions affecting the heme synthesis pathway. It is classified as FDA Class 1, indicating low risk and requiring only general controls without a premarket notification. The product code is JKJ, regulated under 21 CFR 862.1595, within the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JKJ
- Device Class
- FDA class 1
- Regulation Number
- 862.1595
- 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 |
|---|---|---|---|---|
| K893038 | PROTOFLUOR Z | Nov 17, 1989 | Substantially Equivalent | Helena Laboratories |
| K871499 | PROTOFLUOR Z | Aug 25, 1987 | Substantially Equivalent | Helena Laboratories |
| K780455 | QUANTITATIVE DETERMINATION OF PORPHYRINS | Jul 27, 1978 | Substantially Equivalent | Whale Scientific, 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.