Panels › Microbiology › Product code JXB · Class 1
Kit, Identification, Yeast
Regulation 866.2660
0510(k)s in 12 months (16 all time)
0recalls in 12 months (6 all time)
2recalls that name a 510(k)
Top companies in JXB
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomerieux Inc | 0 | 4 |
| Remel Co. | 2 | 2 |
| Advandx, Inc. | 2 | 0 |
| Analytical Products, Inc. | 2 | 0 |
| Vitek Systems, Inc. | 2 | 0 |
| Abbott Laboratories | 1 | 0 |
| American Micro Scan | 1 | 0 |
| Diagnostic Markers, Inc. | 1 | 0 |
| Diagnostica, Inc. | 1 | 0 |
| Immuno-Mycologics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 12, 2008 | K080719 | YEAST TRAFFIC LIGHT PNA FISH Advandx, Inc. | JXB |
| Oct 25, 2006 | K062461 | C. ALBICANS PNA FISH Advandx, Inc. | JXB |
| Feb 10, 2000 | K993554 | YEASTEST Diagnostic Markers, Inc. | JXB |
| Jan 27, 1995 | K943621 | RAPID YEAST PLUS SYSTEM Innovative Diagnostic Systems, Inc. | JXB |
| Feb 25, 1994 | K935124 | BACTICARD CANDIDA Remel Co. | JXB |
| Jul 31, 1990 | K900112 | MICRORING YT Medical Wire & Equipment Co. | JXB |
| Jun 16, 1988 | K881925 | VITEK YEAST BIOCHEMICAL CARD Vitek Systems, Inc. | JXB |
| May 13, 1986 | K860575 | YEAST IDENTIFICATION PANEL American Micro Scan | JXB |
| Apr 5, 1983 | K830286 | YEAST IDENT Analytical Products, Inc. | JXB |
| Dec 1, 1980 | K802309 | MS-2 IDENTIFICATION SYSTEM Abbott Laboratories | JXB |
| Jul 8, 1980 | K800803 | NITRATE SWAB-RAPID TEST Remel Co. | JXB |
| Jun 2, 1980 | K800908 | CAPIK-CANDIDA ALBICANS IDENT. KIT. Immuno-Mycologics, Inc. | JXB |
| Dec 19, 1979 | K792231 | AMS YEAST BIOCHEMICAL CARD Vitek Systems, Inc. | JXB |
| Jun 22, 1979 | K790991 | YEAST-PALETTE TM Micro-Palettes, Inc. | JXB |
| May 31, 1979 | K790671 | DERMATOPHYTIN O Diagnostica, Inc. | JXB |
| Aug 3, 1977 | K771008 | API 20C Analytical Products, Inc. | JXB |
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