Staphytect Plus/Dryspot Staphytect Plus
FDA 510(k) K972030 · Oxoid , Ltd.
510(k) numberK972030
Submission
- Device name
- Staphytect Plus/Dryspot Staphytect Plus
- Applicant
- Oxoid , Ltd.
Basingstoke, GB - Received
- June 2, 1997
- Decision date
- September 8, 1997
- 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
Other 510(k)s with product code JWX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K090964 | Binaxnox Staphylococcus Aureus TestJWX · Traditional | Binax, Inc. | 12/16/2009SE |
| 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 |
| K855220 | V-Trend Kit Staph Latex TestJWX · Traditional | Texas Immunology, Inc. | 03/03/1986SE |
More from Texas Immunology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K070262 | Ertapenem Antimicrobial Susceptibility Test DiscJTN · Traditional | 03/14/2007SE |
| K060286 | Tigecycline Antimicrobial Susceptibility Test DiscJTN · Traditional | 03/17/2006SE |
| K042157 | Daptomycin Antimicrobial Susceptibility Test DiscJTN · Traditional | 09/14/2004SE |
| K011710 | Oxoid PBP2 1 Latex Agglutination TestMYI · Traditional | 04/02/2002SE |
| K012588 | Oxoid Pylori Test Kit, Model DR0130MLYR · Traditional | 12/10/2001SE |
| K010537 | Linezolid Antimicrobial Susceptibility Test DiscJTN · Traditional | 04/24/2001SE |
| K010536 | Moxifloxacin Antimicrobial Susceptibility Test DiscJTN · Traditional | 04/24/2001SE |
| K000930 | Gatifloxacin Antimicrobial Susceptibility Test DiscJTN · Traditional | 05/22/2000SE |
| K000928 | Quinupristin/Dalfopristin Antimicrobial Susceptibility Test DiscJTN · Traditional | 05/15/2000SE |
| K993401 | Dryspot E.Coli 0157 KitGNA · Traditional | 02/28/2000SE |
Questions and answers
When was Staphytect Plus/Dryspot Staphytect Plus cleared by the FDA?
Staphytect Plus/Dryspot Staphytect Plus (K972030) received a 510(k) decision of Substantially Equivalent on September 8, 1997, 98 days after the submission was received.
What is the product code of K972030?
The FDA product code is JWX – Kit, Screening, Staphylococcus Aureus, a Class I (low risk) device regulated under 21 CFR 866.2660.