JID · Photometric Method, Ammonia
Clinical Chemistry · 21 CFR 862.1065 · Class 1
Overview
| Product Code | JID |
|---|---|
| Device Name | Photometric Method, Ammonia |
| Regulation | 21 CFR 862.1065 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.
Classification Rationale
Class I.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K991371 | CARESIDE AMMONIA | Careside, Inc. | Aug 3, 1999 | SESE |
| K820723 | KODAK EKTACHEM CLINICAL CHEM. NH3 | Eastman Kodak Company | Apr 1, 1982 | SESE |
| K813366 | AMMONIA TEST | Wako Pure Chemical Industries, Ltd. | Dec 22, 1981 | SESE |
Top Applicants
- Careside, Inc. — 1 clearance
- Eastman Kodak Company — 1 clearance
- Wako Pure Chemical Industries, Ltd. — 1 clearance
