Rapid Yeast Plus System
FDA 510(k) K943621 · Innovative Diagnostic Systems, Inc.
510(k) numberK943621
Submission
- Device name
- Rapid Yeast Plus System
- Applicant
- Innovative Diagnostic Systems, Inc.
Atlanta, GA, US - Received
- July 27, 1994
- Decision date
- January 27, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JXB – Kit, Identification, Yeast
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JXB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K080719 | Yeast Traffic Light Pna FishJXB · Traditional | Advandx, Inc. | 09/12/2008SE |
| K062461 | C. Albicans Pna FishJXB · Traditional | Advandx, Inc. | 10/25/2006SE |
| K993554 | YeastestJXB · Traditional | Diagnostic Markers, Inc. | 02/10/2000SE |
| K935124 | Bacticard CandidaJXB · Traditional | Remel Co. | 02/25/1994SE |
| K900112 | Microring YtJXB · Traditional | Medical Wire & Equipment Co. | 07/31/1990SE |
| K881925 | Vitek Yeast Biochemical CardJXB · Traditional | Vitek Systems, Inc. | 06/16/1988SE |
| K860575 | Yeast Identification PanelJXB · Traditional | American Micro Scan | 05/13/1986SE |
| K830286 | Yeast IdentJXB · Traditional | Analytical Products, Inc. | 04/05/1983SE |
| K802309 | MS-2 Identification SystemJXB · Traditional | Abbott Laboratories | 12/01/1980SE |
| K800803 | Nitrate Swab-Rapid TestJXB · Traditional | Remel Co. | 07/08/1980SE |
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| K962966 | Ids Rapid CB Plus SystemJTO · Traditional | 10/08/1996SE |
| K900517 | Rapid NF SystemJSW · Traditional | 03/13/1990SE |
| K882960 | Ids Rapid Ana SystemJSP · Traditional | 08/12/1988SE |
| K881501 | Modified Ids Rapid NH SystemJSX · Traditional | 05/18/1988SE |
| K852871 | Ids Rapid Ss/U SystemJSS · Traditional | 07/23/1985SE |
| K852110 | Ids Rapid E Plus SystemJSS · Traditional | 06/04/1985SE |
| K833654 | Ids Rapid STR SystemJTO · Traditional | 02/13/1984SE |
| K822144 | Ids Staphylochrome TestJWX · Traditional | 08/24/1982SE |
| K820483 | Ida Rapid O2A SystemJSP · Traditional | 03/15/1982SE |
| K812859 | Ids Porphyrin ReagentJTO · Traditional | 10/26/1981SE |
Questions and answers
When was Rapid Yeast Plus System cleared by the FDA?
Rapid Yeast Plus System (K943621) received a 510(k) decision of Substantially Equivalent on January 27, 1995, 184 days after the submission was received.
What is the product code of K943621?
The FDA product code is JXB – Kit, Identification, Yeast, a Class I (low risk) device regulated under 21 CFR 866.2660.