BBL Staphyslide Test
FDA 510(k) K821962 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK821962
Submission
- Device name
- BBL Staphyslide Test
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington, DC, US - Received
- July 1, 1982
- Decision date
- July 30, 1982
- 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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| K003461 | BD Vacutainer Passive Shielding Blood Collection NeedleFMI · Traditional | 02/01/2001SE |
| K002938 | B-D Ultra-Fine III Pen Needle; Model 31G X 3/16FMI · Traditional | 11/29/2000SE |
| K001364 | BD Directigen Flu A+BPSZ · Traditional | 06/28/2000SE |
| K000762 | Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/25/2000SE |
| K000829 | Gatifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/13/2000SE |
| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
| K992734 | Becton Dickinson SyringeMEG · Traditional | 10/01/1999SE |
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Questions and answers
When was BBL Staphyslide Test cleared by the FDA?
BBL Staphyslide Test (K821962) received a 510(k) decision of Substantially Equivalent on July 30, 1982, 29 days after the submission was received.
What is the product code of K821962?
The FDA product code is JWX – Kit, Screening, Staphylococcus Aureus, a Class I (low risk) device regulated under 21 CFR 866.2660.