JJH — Clinical Sample Concentrator Class I
FDA product code JJH covers "Clinical Sample Concentrator", a Class I medical device regulated under 21 CFR 862.2310. Submissions are reviewed by the Clinical Chemistry panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JJH
- Device Class
- Class I
- Regulation Number
- 862.2310
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K113731 | clinical micro sensors | ESENSOR RESPIRATORY VIRAL PANEL | September 10, 2012 |
| K960298 | vivascience | VIVASPIN 4 10,000 MW | March 19, 1996 |
| K943966 | vivascience | VIVAPORE 2 | April 11, 1995 |
| K943965 | vivascience | VIVAPORE 10 | April 11, 1995 |
| K941326 | millipore | ULTRAFREE-CL | May 27, 1994 |
| K935496 | intersep | NANOSEP N10 | April 26, 1994 |
| K930168 | amicon | CENTRICON -50 CONCENTRATOR | August 5, 1993 |
| K893733 | amicon | CENTRICON CONCENTRATOR | July 20, 1989 |
| K871290 | polysciences | CENTRICELL(TM) | August 5, 1987 |
| K870690 | amicon | CENTRIPREP CONCENTRATOR | March 19, 1987 |
| K851393 | e.i. dupont de nemours and co | DUPONT PREP FOUR-SOLVENT RETROFIT KIT | July 12, 1985 |
| K833919 | amicon | CENTRICON MICRO-CONCENTRATOR | January 30, 1984 |
| K801772 | radiation technology | MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG | August 20, 1980 |
| K770398 | amicon | MINICON | April 6, 1977 |
| K760592 | amicon | MINICON CONCENTRATOR | November 23, 1976 |