Photometric Method, Ammonia
Photometric Method for Ammonia is a clinical chemistry test system that uses photometric detection to quantify ammonia concentration in blood, used in the diagnosis and monitoring of hyperammonemia, liver failure, and urea cycle disorders. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is JID, regulated under 21 CFR 862.1065, within the Clinical Chemistry medical specialty. This device is eligible for third-party review where applicable.
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Basic Information
- Product Code
- JID
- Device Class
- FDA class 1
- Regulation Number
- 862.1065
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
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 |
|---|---|---|---|---|
| K991371 | CARESIDE AMMONIA | Aug 03, 1999 | Substantially Equivalent | Careside, Inc. |
| K820723 | KODAK EKTACHEM CLINICAL CHEM. NH3 | Apr 01, 1982 | Substantially Equivalent | Eastman Kodak Company |
| K813366 | AMMONIA TEST | Dec 22, 1981 | Substantially Equivalent | Wako Pure Chemical Industries, Ltd. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.