Panels › Clinical Chemistry › Product code JJH · Class 1
Clinical Sample Concentrator
Regulation 862.2310
0510(k)s in 12 months (15 all time)
1recalls in 12 months (32 all time)
5recalls that name a 510(k)
Top companies in JJH
| Company | 510(k)s | Recalls |
|---|---|---|
| Entopsis , Inc. | 0 | 7 |
| Amicon, Inc. | 6 | 0 |
| Qiagen Sciences LLC | 0 | 6 |
| Abbott Molecular | 0 | 5 |
| Roche Molecular Systems, Inc. | 0 | 5 |
| Becton Dickinson & Co. | 0 | 3 |
| Vivascience, Inc. | 3 | 0 |
| BioMerieux SA | 0 | 2 |
| Clinical Micro Sensors, Inc. | 1 | 0 |
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 10, 2012 | K113731 | ESENSOR RESPIRATORY VIRAL PANEL Clinical Micro Sensors, Inc. | JJH |
| Mar 19, 1996 | K960298 | VIVASPIN 4 10,000 MW Vivascience, Inc. | JJH |
| Apr 11, 1995 | K943966 | VIVAPORE 2 Vivascience, Inc. | JJH |
| Apr 11, 1995 | K943965 | VIVAPORE 10 Vivascience, Inc. | JJH |
| May 27, 1994 | K941326 | ULTRAFREE-CL Millipore Corp. | JJH |
| Apr 26, 1994 | K935496 | NANOSEP N10 Intersep , Ltd., GB | JJH |
| Aug 5, 1993 | K930168 | CENTRICON -50 CONCENTRATOR Amicon, Inc. | JJH |
| Jul 20, 1989 | K893733 | CENTRICON CONCENTRATOR Amicon, Inc. | JJH |
| Aug 5, 1987 | K871290 | CENTRICELL(TM) Polysciences, Inc. | JJH |
| Mar 19, 1987 | K870690 | CENTRIPREP CONCENTRATOR Amicon, Inc. | JJH |
| Jul 12, 1985 | K851393 | DUPONT PREP FOUR-SOLVENT RETROFIT KIT E.I. Dupont DE Nemours & Co., Inc. | JJH |
| Jan 30, 1984 | K833919 | CENTRICON MICRO-CONCENTRATOR Amicon, Inc. | JJH |
| Aug 20, 1980 | K801772 | MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG Radiation Technology, Inc. | JJH |
| Apr 6, 1977 | K770398 | MINICON Amicon, Inc. | JJH |
| Nov 23, 1976 | K760592 | MINICON CONCENTRATOR Amicon, Inc. | JJH |
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