Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart C — Clinical Laboratory Instruments](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments) → [21 CFR 862.2310](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2310) → OUL — Thermocycler, Generic

# OUL · Thermocycler, Generic

_Clinical Chemistry · 21 CFR 862.2310 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/OUL

## Overview

- **Product Code:** OUL
- **Device Name:** Thermocycler, Generic
- **Regulation:** [21 CFR 862.2310](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2310)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## 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._

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/OUL](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/OUL)

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