Vitek Yeast Biochemical Card
FDA 510(k) K881925 · Vitek Systems, Inc.
510(k) numberK881925
Submission
- Device name
- Vitek Yeast Biochemical Card
- Applicant
- Vitek Systems, Inc.
Hazelwood, MI, US - Received
- May 9, 1988
- Decision date
- June 16, 1988
- 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 |
| K900112 | Microring YtJXB · Traditional | Medical Wire & Equipment Co. | 07/31/1990SE |
| 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 |
|---|---|---|
| K920661 | Vidas CMV Igg AssayLFZ · Traditional | 02/12/1993SE |
| K921302 | Vitek Immunodiagnostic Assay SystemJHI · Traditional | 07/28/1992SE |
| K921176 | Vitek Immunodiagnostic Assay SystemCEP · Traditional | 04/08/1992SE |
| K920952 | Vitek Immunodiag Assay Syst(Vidas) Ferritine AssayDBF · Traditional | 04/07/1992SE |
| K915884 | Vidas Chlamydia Assay, ModificationLJC · Traditional | 03/04/1992SE |
| K905211 | Vidas Clostridium Difficile Toxin a (Cda) AssayLLH · Traditional | 10/11/1991SE |
| K912371 | Biomerieux RSV Direct If KitLKT · Traditional | 09/23/1991SE |
| K910230 | Lyme-Spot If KitLSR · Traditional | 08/30/1991SE |
| K910210 | Slidex Meningite-Kit 5GTJ · Traditional | 08/12/1991SE |
| K910304 | Rapid Coryne Syst/Identif of Coryneform BacteriaLQL · Traditional | 07/26/1991SE |
Questions and answers
When was Vitek Yeast Biochemical Card cleared by the FDA?
Vitek Yeast Biochemical Card (K881925) received a 510(k) decision of Substantially Equivalent on June 16, 1988, 38 days after the submission was received.
What is the product code of K881925?
The FDA product code is JXB – Kit, Identification, Yeast, a Class I (low risk) device regulated under 21 CFR 866.2660.