Product code JXB
- Device name
- Kit, Identification, Yeast
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2660
- Review panel
- MI
- 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 |
|---|---|---|---|
| K080719 | YEAST TRAFFIC LIGHT PNA FISH | Advandx, Inc. | 2008-09-12 |
| K062461 | C. ALBICANS PNA FISH | Advandx, Inc. | 2006-10-25 |
| K993554 | YEASTEST | Diagnostic Markers, Inc. | 2000-02-10 |
| K943621 | RAPID YEAST PLUS SYSTEM | Innovative Diagnostic Systems, Inc. | 1995-01-27 |
| K935124 | BACTICARD CANDIDA | Remel Co. | 1994-02-25 |
| K900112 | MICRORING YT | Medical Wire & Equipment Co. | 1990-07-31 |
| K881925 | VITEK YEAST BIOCHEMICAL CARD | Vitek Systems, Inc. | 1988-06-16 |
| K860575 | YEAST IDENTIFICATION PANEL | American Micro Scan | 1986-05-13 |
| K830286 | YEAST IDENT | Analytical Products, Inc. | 1983-04-05 |
| K802309 | MS-2 IDENTIFICATION SYSTEM | Abbott Laboratories | 1980-12-01 |
| K800803 | NITRATE SWAB-RAPID TEST | Remel Co. | 1980-07-08 |
| K800908 | CAPIK-CANDIDA ALBICANS IDENT. KIT. | Immuno-Mycologics, Inc. | 1980-06-02 |
| K792231 | AMS YEAST BIOCHEMICAL CARD | Vitek Systems, Inc. | 1979-12-19 |
| K790991 | YEAST-PALETTE TM | Micro-Palettes, Inc. | 1979-06-22 |
| K790671 | DERMATOPHYTIN O | Diagnostica, Inc. | 1979-05-31 |
| K771008 | API 20C | Analytical Products, Inc. | 1977-08-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00848838058455 | Remel™ RapID™ ERIC™ (ELECTRONIC RAPID IDENTIFICATION COMPENDIUM) | REMEL, INC. | 2024-11-13 |
| 00848838022432 | BACTICARD | REMEL, INC. | 2022-12-23 |
| 15099590658106 | MicroScan | Beckman Coulter, Inc. | 2022-12-05 |
| 15099590655716 | MicroScan | Beckman Coulter, Inc. | 2022-11-15 |
| 15099590655792 | MicroScan | Beckman Coulter, Inc. | 2022-11-15 |
| 15099590655839 | MicroScan | Beckman Coulter, Inc. | 2022-11-15 |
| 00848838058233 | Remel | REMEL, INC. | 2021-11-12 |
| 30848838058234 | Remel | REMEL, INC. | 2021-11-12 |
| 03848838058230 | Remel | REMEL, INC. | 2021-11-12 |
| 03573026529697 | VITEK® 2 YST | BIOMERIEUX , INC. | 2020-06-02 |
| 03573026131937 | VITEK® 2 YST | BIOMERIEUX , INC. | 2020-06-02 |
| 03573026048082 | API® 20 C AUX | BIOMERIEUX SA | 2020-04-10 |
| 03573026066383 | ID 32 C | BIOMERIEUX SA | 2020-04-10 |
| 00382904483166 | BD Phoenix™ YEAST ID | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 30382904483167 | BD Phoenix™ Yeast ID | BECTON, DICKINSON AND COMPANY | 2018-05-25 |