C. ALBICANS PNA FISH
FDA 510(k) clearance K062461 · decided 2006-10-25
Clearance details
- K-number
- K062461
- Device name
- C. ALBICANS PNA FISH
- Applicant
- Advandx, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-08-23
- Decision date
- 2006-10-25
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- JXB
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Canton, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| YEAST TRAFFIC LIGHT PNA FISH (K080719) | Advandx, Inc. | 2008-09-12 |
| YEASTEST (K993554) | Diagnostic Markers, Inc. | 2000-02-10 |
| RAPID YEAST PLUS SYSTEM (K943621) | Innovative Diagnostic Systems, Inc. | 1995-01-27 |
| BACTICARD CANDIDA (K935124) | Remel Co. | 1994-02-25 |
| MICRORING YT (K900112) | Medical Wire & Equipment Co. | 1990-07-31 |
| VITEK YEAST BIOCHEMICAL CARD (K881925) | Vitek Systems, Inc. | 1988-06-16 |
| YEAST IDENTIFICATION PANEL (K860575) | American Micro Scan | 1986-05-13 |
| YEAST IDENT (K830286) | Analytical Products, Inc. | 1983-04-05 |
| MS-2 IDENTIFICATION SYSTEM (K802309) | Abbott Laboratories | 1980-12-01 |
| NITRATE SWAB-RAPID TEST (K800803) | Remel Co. | 1980-07-08 |
| CAPIK-CANDIDA ALBICANS IDENT. KIT. (K800908) | Immuno-Mycologics, Inc. | 1980-06-02 |
| AMS YEAST BIOCHEMICAL CARD (K792231) | Vitek Systems, Inc. | 1979-12-19 |
Recalls involving this device
No recalls on record reference this clearance.