JLA · Conversion To Creatinine, Creatine
Clinical Chemistry · 21 CFR 862.1210 · Class 1
Overview
| Product Code | JLA |
|---|---|
| Device Name | Conversion To Creatinine, Creatine |
| Regulation | 21 CFR 862.1210 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A creatine test system is a device intended to measure creatine (a substance synthesized in the liver and pancreas and found in biological fluids) in plasma, serum, and urine. Measurements of creatine are used in the diagnosis and treatment of muscle diseases and endocrine disorders including hyperthyroidism.
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 |
|---|---|---|---|---|
| K852767 | ERYTHOCYTE CREATINE | Panmed, Inc. | Nov 13, 1986 | SESE |
| K854016 | ASSERACHROM PROTEIN C KIT | American Bioproducts Co. | Jan 3, 1986 | SESE |
Top Applicants
- American Bioproducts Co. — 1 clearance
- Panmed, Inc. — 1 clearance
