Ids Staphylochrome Test
FDA 510(k) K822144 · Innovative Diagnostic Systems, Inc.
510(k) numberK822144
Submission
- Device name
- Ids Staphylochrome Test
- Applicant
- Innovative Diagnostic Systems, Inc.
Atlanta, GA, US - Received
- July 21, 1982
- Decision date
- August 24, 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 |
More from American Micro Scan
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|---|---|---|
| K962966 | Ids Rapid CB Plus SystemJTO · Traditional | 10/08/1996SE |
| K943621 | Rapid Yeast Plus SystemJXB · Traditional | 01/27/1995SE |
| K900517 | Rapid NF SystemJSW · Traditional | 03/13/1990SE |
| K882960 | Ids Rapid Ana SystemJSP · Traditional | 08/12/1988SE |
| K881501 | Modified Ids Rapid NH SystemJSX · Traditional | 05/18/1988SE |
| K852871 | Ids Rapid Ss/U SystemJSS · Traditional | 07/23/1985SE |
| K852110 | Ids Rapid E Plus SystemJSS · Traditional | 06/04/1985SE |
| K833654 | Ids Rapid STR SystemJTO · Traditional | 02/13/1984SE |
| K820483 | Ida Rapid O2A SystemJSP · Traditional | 03/15/1982SE |
| K812859 | Ids Porphyrin ReagentJTO · Traditional | 10/26/1981SE |
Questions and answers
When was Ids Staphylochrome Test cleared by the FDA?
Ids Staphylochrome Test (K822144) received a 510(k) decision of Substantially Equivalent on August 24, 1982, 34 days after the submission was received.
What is the product code of K822144?
The FDA product code is JWX – Kit, Screening, Staphylococcus Aureus, a Class I (low risk) device regulated under 21 CFR 866.2660.