JJH · Clinical Sample Concentrator
Clinical Chemistry · 21 CFR 862.2310 · Class 1
Overview
| Product Code | JJH |
|---|---|
| Device Name | Clinical Sample Concentrator |
| 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 (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K113731 | ESENSOR RESPIRATORY VIRAL PANEL | Clinical Micro Sensors, Inc. | Sep 10, 2012 | SESE |
| K960298 | VIVASPIN 4 10,000 MW | Vivascience, Inc. | Mar 19, 1996 | SESE |
| K943966 | VIVAPORE 2 | Vivascience, Inc. | Apr 11, 1995 | SESE |
| K943965 | VIVAPORE 10 | Vivascience, Inc. | Apr 11, 1995 | SESE |
| K941326 | ULTRAFREE-CL | Millipore Corp. | May 27, 1994 | SESE |
| K935496 | NANOSEP N10 | Intersep , Ltd. | Apr 26, 1994 | SESE |
| K930168 | CENTRICON -50 CONCENTRATOR | Amicon, Inc. | Aug 5, 1993 | SESE |
| K893733 | CENTRICON CONCENTRATOR | Amicon, Inc. | Jul 20, 1989 | SESE |
| K871290 | CENTRICELL(TM) | Polysciences, Inc. | Aug 5, 1987 | SESE |
| K870690 | CENTRIPREP CONCENTRATOR | Amicon, Inc. | Mar 19, 1987 | SESE |
| K851393 | DUPONT PREP FOUR-SOLVENT RETROFIT KIT | E.I. Dupont DE Nemours & Co., Inc. | Jul 12, 1985 | SESE |
| K833919 | CENTRICON MICRO-CONCENTRATOR | Amicon, Inc. | Jan 30, 1984 | SESE |
| K801772 | MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG | Radiation Technology, Inc. | Aug 20, 1980 | SESE |
| K770398 | MINICON | Amicon, Inc. | Apr 6, 1977 | SESE |
| K760592 | 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
