Product code JJH
- Device name
- Clinical Sample Concentrator
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2310
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K113731 | ESENSOR RESPIRATORY VIRAL PANEL | Clinical Micro Sensors, Inc. | 2012-09-10 |
| K960298 | VIVASPIN 4 10,000 MW | Vivascience, Inc. | 1996-03-19 |
| K943965 | VIVAPORE 10 | Vivascience, Inc. | 1995-04-11 |
| K943966 | VIVAPORE 2 | Vivascience, Inc. | 1995-04-11 |
| K941326 | ULTRAFREE-CL | Millipore Corp. | 1994-05-27 |
| K935496 | NANOSEP N10 | Intersep , Ltd. | 1994-04-26 |
| K930168 | CENTRICON -50 CONCENTRATOR | Amicon, Inc. | 1993-08-05 |
| K893733 | CENTRICON CONCENTRATOR | Amicon, Inc. | 1989-07-20 |
| K871290 | CENTRICELL(TM) | Polysciences, Inc. | 1987-08-05 |
| K870690 | CENTRIPREP CONCENTRATOR | Amicon, Inc. | 1987-03-19 |
| K851393 | DUPONT PREP FOUR-SOLVENT RETROFIT KIT | E.I. Dupont DE Nemours & Co., Inc. | 1985-07-12 |
| K833919 | CENTRICON MICRO-CONCENTRATOR | Amicon, Inc. | 1984-01-30 |
| K801772 | MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG | Radiation Technology, Inc. | 1980-08-20 |
| K770398 | MINICON | Amicon, Inc. | 1977-04-06 |
| K760592 | MINICON CONCENTRATOR | Amicon, Inc. | 1976-11-23 |
Related GUDID Devices#
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|---|---|---|---|
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| 10190302017800 | Ion Torrent™ Genexus™ Dx Purification instrument | LIFE TECHNOLOGIES HOLDINGS PTE. LTD. | 2025-10-13 |
| 16974488990744 | iClean | Huachenyang (Shenzhen) Technology Co., Ltd | 2023-11-28 |
| 00816862024104 | Wondfo | WONDFO USA CO., LTD. | 2023-08-11 |
| 20812125010079 | Acuitas | Opgen, Inc. | 2023-04-28 |
| 10190302018241 | MagMAX™ Viral/Pathogen II Nucleic Acid Isolation Kit | THERMO FISHER SCIENTIFIC BALTICS UAB | 2023-03-22 |
| 00810047420576 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420217 | N/A | Scientific Device Laboratory, Inc. | 2023-01-30 |
| 00810047420200 | N/A | Scientific Device Laboratory, Inc. | 2023-01-30 |
| B5507870030 | PCRopsis | ENTOPSIS, LLC | 2023-01-19 |
| 08809886490002 | Nucleic Acid Extractor | HANWOOLTPC Co., Ltd. | 2022-12-14 |
| 08809886490019 | Nucleic Acid Extractor | HANWOOLTPC Co., Ltd. | 2022-12-14 |
| B708XCPSPC1200 | XCELL | APEX BIOLOGIX , LLC | 2022-11-16 |
| B5505972504 | PCRopsis | ENTOPSIS, LLC | 2022-05-31 |
| B5505978503 | PCRopsis | ENTOPSIS, LLC | 2022-05-05 |
| 00850040712155 | Mawi DNA Technologies | Mawi Dna Technologies, LLC | 2022-04-06 |
| 01812125010074 | Acuitas | Opgen, Inc. | 2021-10-25 |
| B5502668503 | PCRopsis | ENTOPSIS, LLC | 2021-05-13 |
| B55026682504 | PCRopsis | ENTOPSIS, LLC | 2021-05-13 |
| 08806133010242 | NuActor | Boditech Med Inc. | 2020-06-16 |
| 15420045510463 | Panther Fusion® | Hologic, Inc. | 2019-07-30 |
| 10190302005807 | Ion Torrent | LIFE TECHNOLOGIES CORPORATION | 2018-06-28 |
| 10190302005791 | Ion Torrent | LIFE TECHNOLOGIES CORPORATION | 2018-06-28 |
| 10190302005784 | Ion Torrent | LIFE TECHNOLOGIES CORPORATION | 2018-06-28 |
| 10190302005258 | Ion Torrent | LIFE TECHNOLOGIES CORPORATION | 2018-06-28 |
| 15420045509214 | Panther Fusion® | Hologic, Inc. | 2017-11-08 |
| 10190302006323 | Ion Torrent™Dx Sample Dilution Kit | LIFE TECHNOLOGIES CORPORATION | 2017-06-28 |
| 00840487100493 | xTAG® Gastrointestinal Pathogen Panel (GPP) | Luminex Molecular Diagnostics, Inc | 2016-09-09 |
| 00884999006522 | m2000 | ABBOTT MOLECULAR INC. | 2016-09-01 |
| 00884999006539 | m2000 | ABBOTT MOLECULAR INC. | 2016-09-01 |