Microring Yt
FDA 510(k) K900112 · Medical Wire & Equipment Co.
510(k) numberK900112
Submission
- Device name
- Microring Yt
- Applicant
- Medical Wire & Equipment Co.
Fairview Park, OH, US - Received
- January 9, 1990
- Decision date
- July 31, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K943621 | Rapid Yeast Plus SystemJXB · Traditional | Innovative Diagnostic Systems, Inc. | 01/27/1995SE |
| K935124 | Bacticard CandidaJXB · Traditional | Remel Co. | 02/25/1994SE |
| 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 |
More from Remel Co.
| 510(k) | Device | Decision |
|---|---|---|
| K872213 | Transtube MW176 Ot MD176JSM · Traditional | 06/23/1987SE |
Questions and answers
When was Microring Yt cleared by the FDA?
Microring Yt (K900112) received a 510(k) decision of Substantially Equivalent on July 31, 1990, 203 days after the submission was received.
What is the product code of K900112?
The FDA product code is JXB – Kit, Identification, Yeast, a Class I (low risk) device regulated under 21 CFR 866.2660.