Sero-Stat Staphylococcus Test
FDA 510(k) K811098 · Scott Laboratories, Inc.
510(k) numberK811098
Submission
- Device name
- Sero-Stat Staphylococcus Test
- Applicant
- Scott Laboratories, Inc.
Mchenry, IL, US - Received
- April 22, 1981
- Decision date
- May 5, 1981
- 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 |
More from American Micro Scan
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|---|---|---|
| K880694 | B. Cat ConfirmJTO · Traditional | 06/16/1988SE |
| K874933 | Mug-Indole DiscJTO · Traditional | 01/05/1988SE |
| K874662 | Myco-Fluor Reagent a & BJTS · Traditional | 11/25/1987SE |
| K873509 | Identicult-BlJTO · Traditional | 10/15/1987SE |
| K871238 | AnabagKZJ · Traditional | 04/03/1987SE |
| K863025 | Sero-Stat R II Staphylococcus TestLHT · Traditional | 09/15/1986SE |
| K852869 | Selecticult-ChlamydiaLKH · Traditional | 09/19/1985SE |
| K852832 | Identicult-NeisseriaJTO · Traditional | 07/19/1985SE |
| K852666 | Identicult-AeJTO · Traditional | 07/15/1985SE |
| K841680 | Scott Selecticult-Hsv Isolation &GQL · Traditional | 10/30/1984SE |
Questions and answers
When was Sero-Stat Staphylococcus Test cleared by the FDA?
Sero-Stat Staphylococcus Test (K811098) received a 510(k) decision of Substantially Equivalent on May 5, 1981, 13 days after the submission was received.
What is the product code of K811098?
The FDA product code is JWX – Kit, Screening, Staphylococcus Aureus, a Class I (low risk) device regulated under 21 CFR 866.2660.