Staph-A-Lex(Tm) System
FDA 510(k) K926173 · Trinity Laboratories, Inc.
510(k) numberK926173
Submission
- Device name
- Staph-A-Lex(Tm) System
- Applicant
- Trinity Laboratories, Inc.
Raleigh, NC, US - Received
- December 8, 1992
- Decision date
- August 10, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JWX – Kit, Screening, Staphylococcus Aureus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
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|---|---|---|---|
| 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 |
| 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 |
| K855220 | V-Trend Kit Staph Latex TestJWX · Traditional | Texas Immunology, Inc. | 03/03/1986SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K981441 | Heart Cath Tray, Sterile, DisposableDQO · Traditional | 07/10/1998SE |
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| K974286 | Circumcision Tray, Cat. No. 70340HFX · Traditional | 12/12/1997SE |
| K972160 | Crp-Lex System: C-Reactive Protein Antigen Detection in Serum: Slide Agglutnation Latex…DCK · Traditional | 08/01/1997SE |
| K970722 | Eye TrayKKX · Traditional | 03/31/1997SE |
| K965201 | O.R. Scrub Prep Tray, Sterile, DisposableLRO · Traditional | 02/14/1997SEKD |
| K964921 | Basic Biopsy Tray. Disposable, SterileLRO · Traditional | 01/22/1997SE |
| K953929 | Mid-Stream Collection Set-SterileLIO · Traditional | 11/16/1995SE |
| K952058 | Sterile V.A.D. (Vascular Access Devices) Access Kit, DisposableFOZ · Traditional | 09/21/1995SE |
| K953070 | Woundfoam 4 X 4KMF · Traditional | 09/08/1995SE |
Questions and answers
When was Staph-A-Lex(Tm) System cleared by the FDA?
Staph-A-Lex(Tm) System (K926173) received a 510(k) decision of Substantially Equivalent on August 10, 1993, 245 days after the submission was received.
What is the product code of K926173?
The FDA product code is JWX – Kit, Screening, Staphylococcus Aureus, a Class I (low risk) device regulated under 21 CFR 866.2660.