YEAST IDENTIFICATION PANEL
FDA 510(k) clearance K860575 · decided 1986-05-13
Clearance details
- K-number
- K860575
- Device name
- YEAST IDENTIFICATION PANEL
- Applicant
- American Micro Scan
- Decision
- Substantially Equivalent
- Date received
- 1986-02-18
- Decision date
- 1986-05-13
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- JXB
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- West Sacramento, CA, 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 |
| C. ALBICANS PNA FISH (K062461) | Advandx, Inc. | 2006-10-25 |
| 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 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MIC PANELS (N62160/S013) | American Micro Scan | 1985-03-05 |
| MIC PANELS (N62160/S011) | American Micro Scan | 1984-01-30 |
| MIC PANELS (N62160/S012) | American Micro Scan | 1984-01-30 |
| MIC PANELS (N62160/S010) | American Micro Scan | 1983-10-12 |
| MIC PANELS (N62160/S009) | American Micro Scan | 1983-09-28 |
| MIC PANELS (N62160/S008) | American Micro Scan | 1983-08-10 |
| MIC PANELS (N62160/S007) | American Micro Scan | 1983-02-03 |
| MIC PANELS (N62160/S006) | American Micro Scan | 1982-11-18 |