OUL · Thermocycler, Generic
Clinical Chemistry · 21 CFR 862.2310 · Class 1
Overview
| Product Code | OUL |
|---|---|
| Device Name | Thermocycler, Generic |
| Regulation | 21 CFR 862.2310 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A clinical sample concentrator is a device intended to concentrate (by dialysis, evaporation, etc.) serum, urine, cerebrospinal fluid, and other body fluids before the fluids are analyzed.
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 (0 of 0)
No cleared devices on record.
