Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart C — Clinical Laboratory Instruments](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments) → [21 CFR 862.2680](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2680) → JRA — Microtitrator, For Clinical Use

# JRA · Microtitrator, For Clinical Use

_Clinical Chemistry · 21 CFR 862.2680 · Class 1_

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

## Overview

- **Product Code:** JRA
- **Device Name:** Microtitrator, For Clinical Use
- **Regulation:** [21 CFR 862.2680](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2680)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A microtitrator for clinical use is a device intended for use in micronanalysis to measure the concentration of a substance by reacting it with a measure “micro” volume of a known standardized solution.

## 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 § 862.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K963268](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRA/K963268.md) | GENESIS RMP | Tecan U.S., Inc. | Mar 18, 1997 | SESE |

## Top Applicants

- Tecan U.S., Inc. — 1 clearance

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

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