V-Trend Kit Staph Latex Test
FDA 510(k) K855220 · Texas Immunology, Inc.
510(k) numberK855220
Submission
- Device name
- V-Trend Kit Staph Latex Test
- Applicant
- Texas Immunology, Inc.
Selman City, TX, US - Received
- December 30, 1985
- Decision date
- March 3, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JWX – Kit, Screening, Staphylococcus Aureus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JWX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K090964 | Binaxnox Staphylococcus Aureus TestJWX · Traditional | Binax, Inc. | 12/16/2009SE |
| K972030 | Staphytect Plus/Dryspot Staphytect PlusJWX · Traditional | Oxoid , Ltd. | 09/08/1997SE |
| K964315 | Remel Staph Latex KitJWX · Traditional | Remel, L.P. | 02/07/1997SE |
| K945538 | Staphaurex Plus(Tm)JWX · Traditional | Murex Diagnostics Limitd | 06/01/1995SE |
| K926173 | Staph-A-Lex(Tm) SystemJWX · Traditional | Trinity Laboratories, Inc. | 08/10/1993SE |
| K923212 | Slidex Staph-KitJWX · Traditional | Biomerieux Vitek, Inc. | 09/28/1992SE |
| K905617 | Visi-StaphJWX · Traditional | Connecticut Diagnostics, Ltd. | 03/29/1991SE |
| K902259 | Axiom Total Knee System, Tibial ComponentJWX · Traditional | Orthomet, Inc. | 06/18/1990SN |
| K874019 | StaphslideJWX · Traditional | Ncs Diagnostics, Inc. | 10/28/1987SE |
| K854278 | Neg Combo Breakpoint Panel Pos ComboJWX · Traditional | American Micro Scan | 03/04/1986SE |
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|---|---|---|
| K991465 | Drug StopMVO · Traditional | 12/10/1999SE |
| K980153 | Drug CheckDIO · Traditional | 03/27/1998SE |
| K973208 | First SignLCX · Traditional | 10/20/1997SE |
| K972094 | Target Cardiac Troponin I TestMMI · Traditional | 07/23/1997SE |
| K963680 | Target Myoglobin TestDDR · Traditional | 02/06/1997SE |
| K912246 | Target Microalbuminuria TestJIR · Traditional | 07/19/1991SE |
| K910073 | Target Aso TestGTQ · Traditional | 05/21/1991SE |
| K904105 | V-Trend Target RF TestDHR · Traditional | 10/15/1990SE |
| K892231 | V-Trend Target CRP TestDCN · Traditional | 04/21/1989SE |
| K890423 | V-Trend Target CRP TestDCK · Traditional | 02/17/1989SE |
Questions and answers
When was V-Trend Kit Staph Latex Test cleared by the FDA?
V-Trend Kit Staph Latex Test (K855220) received a 510(k) decision of Substantially Equivalent on March 3, 1986, 63 days after the submission was received.
What is the product code of K855220?
The FDA product code is JWX – Kit, Screening, Staphylococcus Aureus, a Class I (low risk) device regulated under 21 CFR 866.2660.