JMX · Ninhydrin, Nitrogen (Amino-Nitrogen)
Clinical Chemistry · 21 CFR 862.1515 · Class 1
Overview
| Product Code | JMX |
|---|---|
| Device Name | Ninhydrin, Nitrogen (Amino-Nitrogen) |
| Regulation | 21 CFR 862.1515 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A nitrogen (amino-nitrogen) test system is a device intended to measure amino acid nitrogen levels in serum, plasma, and urine. Nitrogen (amino-nitrogen) measurements are used in the diagnosis and treatment of certain forms of severe liver disease and renal disorders.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K863188 | HPL RIA KIT | Biotecx Laboratories, Inc. | Sep 25, 1986 | SESE |
| K780847 | NINHYDRIN REAGENT KIT | Beckman Instruments, Inc. | Jun 13, 1978 | SESE |
Top Applicants
- Beckman Instruments, Inc. — 1 clearance
- Biotecx Laboratories, Inc. — 1 clearance
