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) → JJH — Clinical Sample Concentrator

# JJH · Clinical Sample Concentrator

_Clinical Chemistry · 21 CFR 862.2310 · Class 1_

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

## Overview

- **Product Code:** JJH
- **Device Name:** Clinical Sample Concentrator
- **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 (15 of 15)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K113731](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJH/K113731.md) | ESENSOR RESPIRATORY VIRAL PANEL | Clinical Micro Sensors, Inc. | Sep 10, 2012 | SESE |
| [K960298](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJH/K960298.md) | VIVASPIN 4 10,000 MW | Vivascience, Inc. | Mar 19, 1996 | SESE |
| [K943966](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJH/K943966.md) | VIVAPORE 2 | Vivascience, Inc. | Apr 11, 1995 | SESE |
| [K943965](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJH/K943965.md) | VIVAPORE 10 | Vivascience, Inc. | Apr 11, 1995 | SESE |
| [K941326](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJH/K941326.md) | ULTRAFREE-CL | Millipore Corp. | May 27, 1994 | SESE |
| [K935496](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJH/K935496.md) | NANOSEP N10 | Intersep , Ltd. | Apr 26, 1994 | SESE |
| [K930168](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJH/K930168.md) | CENTRICON -50 CONCENTRATOR | Amicon, Inc. | Aug 5, 1993 | SESE |
| [K893733](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJH/K893733.md) | CENTRICON CONCENTRATOR | Amicon, Inc. | Jul 20, 1989 | SESE |
| [K871290](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJH/K871290.md) | CENTRICELL(TM) | Polysciences, Inc. | Aug 5, 1987 | SESE |
| [K870690](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJH/K870690.md) | CENTRIPREP CONCENTRATOR | Amicon, Inc. | Mar 19, 1987 | SESE |
| [K851393](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJH/K851393.md) | DUPONT PREP FOUR-SOLVENT RETROFIT KIT | E.I. Dupont DE Nemours & Co., Inc. | Jul 12, 1985 | SESE |
| [K833919](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJH/K833919.md) | CENTRICON MICRO-CONCENTRATOR | Amicon, Inc. | Jan 30, 1984 | SESE |
| [K801772](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJH/K801772.md) | MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG | Radiation Technology, Inc. | Aug 20, 1980 | SESE |
| [K770398](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJH/K770398.md) | MINICON | Amicon, Inc. | Apr 6, 1977 | SESE |
| [K760592](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJH/K760592.md) | MINICON CONCENTRATOR | Amicon, Inc. | Nov 23, 1976 | SESE |

## Top Applicants

- Amicon, Inc. — 6 clearances
- Vivascience, Inc. — 3 clearances
- Clinical Micro Sensors, Inc. — 1 clearance
- E.I. Dupont DE Nemours & Co., Inc. — 1 clearance
- Intersep , Ltd. — 1 clearance

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

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