Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart C — Clinical Laboratory Instruments](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments) → [21 CFR 862.2750](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2750) → PER — Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis

# PER · Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis

_Clinical Chemistry · 21 CFR 862.2750 · Class 1_

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

## Overview

- **Product Code:** PER
- **Device Name:** Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
- **Regulation:** [21 CFR 862.2750](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2750)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.

## 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K131301](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/PER/K131301.md) | BD FACS SAMPLE PREP ASSISTANT III | Becton, Dickinson & CO | Aug 2, 2013 | SESE |
| [K130253](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/PER/K130253.md) | TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION | Beckman Coulter, Inc. | Jul 15, 2013 | SESE |
| [K050191](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/PER/K050191.md) | MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE | Becton, Dickinson & CO | Feb 22, 2005 | SESE |

## Top Applicants

- Becton, Dickinson & CO — 2 clearances
- Beckman Coulter, Inc. — 1 clearance

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

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