Clinical Sample Concentrator
This device is a clinical sample concentrator used in laboratory settings to increase the concentration of analytes in specimens prior to analysis, enabling detection of substances present at very low levels that would otherwise fall below the sensitivity threshold of standard assay methods. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket notification required. The product code is JJH, regulated under 21 CFR 862.2310, and assigned to the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JJH
- Device Class
- FDA class 1
- Regulation Number
- 862.2310
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K113731 | ESENSOR RESPIRATORY VIRAL PANEL | Sep 10, 2012 | Substantially Equivalent | Clinical Micro Sensors, Inc. |
| K960298 | VIVASPIN 4 10,000 MW | Mar 19, 1996 | Substantially Equivalent | Vivascience, Inc. |
| K943966 | VIVAPORE 2 | Apr 11, 1995 | Substantially Equivalent | Vivascience, Inc. |
| K943965 | VIVAPORE 10 | Apr 11, 1995 | Substantially Equivalent | Vivascience, Inc. |
| K941326 | ULTRAFREE-CL | May 27, 1994 | Substantially Equivalent | Millipore Corp. |
| K935496 | NANOSEP N10 | Apr 26, 1994 | Substantially Equivalent | Intersep , Ltd. |
| K930168 | CENTRICON -50 CONCENTRATOR | Aug 05, 1993 | Substantially Equivalent | Amicon, Inc. |
| K893733 | CENTRICON CONCENTRATOR | Jul 20, 1989 | Substantially Equivalent | Amicon, Inc. |
| K871290 | CENTRICELL(TM) | Aug 05, 1987 | Substantially Equivalent | Polysciences, Inc. |
| K870690 | CENTRIPREP CONCENTRATOR | Mar 19, 1987 | Substantially Equivalent | Amicon, Inc. |
| K851393 | DUPONT PREP FOUR-SOLVENT RETROFIT KIT | Jul 12, 1985 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
| K833919 | CENTRICON MICRO-CONCENTRATOR | Jan 30, 1984 | Substantially Equivalent | Amicon, Inc. |
| K801772 | MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG | Aug 20, 1980 | Substantially Equivalent | Radiation Technology, Inc. |
| K770398 | MINICON | Apr 06, 1977 | Substantially Equivalent | Amicon, Inc. |
| K760592 | MINICON CONCENTRATOR | Nov 23, 1976 | Substantially Equivalent | Amicon, Inc. |
FEI Numbers
This FDA classification entry is associated with 100 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 100 registration numbers. Click on an entry to view related FDA registrations.