Dermatophytin O
FDA 510(k) K790671 · Diagnostica, Inc.
510(k) numberK790671
Submission
- Device name
- Dermatophytin O
- Applicant
- Diagnostica, Inc.
Mchenry, IL, US - Received
- April 6, 1979
- Decision date
- May 31, 1979
- 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 |
| 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 |
More from Abbott Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K002756 | Ease-A-CultKHE · Traditional | 02/23/2001SE |
| K823348 | H. Influenza B Antisera for CieGRP · Traditional | 12/28/1982SE |
| K812434 | Diagnostic Kits & Kit ComponentsLHT · Traditional | 09/23/1981SE |
| K800398 | Paracontrol Abnormal Immunoglobulin ContDEW · Traditional | 03/12/1980SE |
| K791284 | Anti-Human Kappa SerumDFH · Traditional | 11/27/1979SE |
| K791283 | Anti-Human Lambda SerumDEH · Traditional | 11/27/1979SE |
| K791281 | Anti-Human Igg SerumDEW · Traditional | 11/27/1979SE |
| K791285 | Anti-Human GlobulinsDEW · Traditional | 10/17/1979SE |
| K791282 | Anti-Human SerumDGQ · Traditional | 10/17/1979SE |
| K790672 | Aspergillus Fumigatus, Aspergillus FlavuJWT · Traditional | 05/31/1979SE |
Questions and answers
When was Dermatophytin O cleared by the FDA?
Dermatophytin O (K790671) received a 510(k) decision of Substantially Equivalent on May 31, 1979, 55 days after the submission was received.
What is the product code of K790671?
The FDA product code is JXB – Kit, Identification, Yeast, a Class I (low risk) device regulated under 21 CFR 866.2660.