510(k) K993554
- Device
- YEASTEST
- Applicant
- DIAGNOSTIC MARKERS, INC.
- 510(k) number
- K993554
- Product code
- JXB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-02-10
- Date received
- 1999-10-20
- Regulation
- 866.2660
- Classification name
- Kit, Identification, Yeast
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- GREG HOLLAND
- Address
- 3722 Ave. Sausalito Irvine CA US 92606 92606
FDA Registration Numbers#
- 3013718871
- 3003750284
- 3010132111
- 1119779
- 9610649
- 1924669
- 3009637528
- 9615755
- 2919016
- 9615754
- 1950204
- 3009171251
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JXB #
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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