510(k) K113731
- Device
- ESENSOR RESPIRATORY VIRAL PANEL
- Applicant
- CLINICAL MICRO SENSORS, INC.
- 510(k) number
- K113731
- Product code
- JJH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-09-10
- Date received
- 2011-12-19
- Regulation
- 862.2310
- Classification name
- Clinical Sample Concentrator
- Medical specialty
- Clinical Chemistry
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOEL CENTENO
- Address
- 5964 La Pl. Ct. Carlsbad CA US 92008 92008
FDA Registration Numbers#
- 3003673482
- 1119779
- 3003083993
- 3003795116
- 3013540184
- 3020925311
- 3010594620
- 9610529
- 3003402518
- 3007287152
- 9612003
- 3012101172
- 3017170972
- 3007420875
- 3003335080
- 3008517993
- 3003540236
- 8020892
- 3012259842
- 3013496958
- 3016764932
- 2915796
- 3004530258
- 3028240331
- 3020831613
- 3024647994
- 3016763307
- 3004417597
- 2025606
- 3017098905
- 3015980628
- 3004013603
- 3028944399
- 3009443851
- 3008937712
- 9615754
- 1550222
- 3007143373
- 3038622676
- 3014100717
- 3017434950
- 3016619649
- 3009311010
- 2024800
- 8030996
- 2134567
- 1650733
- 3010031137
- 3005748564
- 2030633
- 3002777243
- 8043379
- 3026035655
- 3013756523
- 3014290238
- 3009155756
- 3018779125
- 3017583200
- 3010030414
- 3009207631
- 8043909
- 3021043070
- 3021269066
- 3019837962
- 3016733849
- 3006786907
- 3009238284
- 3009573214
- 3016068451
- 3011781554
- 3014325803
- 3012494290
- 3018771894
- 3016837106
- 3007054022
- 3002821232
- 3004141078
- 3006198300
- 3016635427
Source Documents#
Other 510(k) Records For Product Code JJH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
Legacy Summary#
summary
FDA Review#
Decision Summary