Modified Ids Rapid NH System
FDA 510(k) K881501 · Innovative Diagnostic Systems, Inc.
510(k) numberK881501
Submission
- Device name
- Modified Ids Rapid NH System
- Applicant
- Innovative Diagnostic Systems, Inc.
Atlanta, GA, US - Received
- April 11, 1988
- Decision date
- May 18, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSX – Kit, Identification, Neisseria Gonorrhoeae
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JSX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960759 | Gonopox Test KitJSX · Traditional | Medtex Laboratories, Inc. | 09/18/1996SE |
| K923566 | Nizyme Test KitJSX · Traditional | Remel Co. | 11/02/1992SE |
| K913456 | Visi-NeisseriaJSX · Traditional | Kev Connecticut Diagnostics, Inc. | 10/11/1991SE |
| K880511 | Xact NeisseriaJSX · Traditional | Austin Biological Laboratories | 08/25/1988SE |
| K870117 | Neisseria/Branhamella Differential TestJSX · Traditional | Pro-Lab, Inc. | 03/20/1987SE |
| K853544 | Quad Ferm +JSX · Traditional | Analytical Products, Inc. | 09/05/1985SE |
| K852998 | Neisseria - Kwik PlusJSX · Traditional | Micro-Bio-Logics | 07/23/1985SE |
| K852582 | Goni-KitJSX · Traditional | Culture Kits, Inc. | 07/12/1985SE |
| K833307 | Phadeback G.C. Positive ControlsJSX · Traditional | Pharmacia, Inc. | 12/27/1983SE |
| K833180 | Gonochek-IiJSX · Traditional | E-Y Laboratories, Inc. | 11/14/1983SE |
More from E-Y Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| 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 |
| K822144 | Ids Staphylochrome TestJWX · Traditional | 08/24/1982SE |
| K820483 | Ida Rapid O2A SystemJSP · Traditional | 03/15/1982SE |
| K812859 | Ids Porphyrin ReagentJTO · Traditional | 10/26/1981SE |
Questions and answers
When was Modified Ids Rapid NH System cleared by the FDA?
Modified Ids Rapid NH System (K881501) received a 510(k) decision of Substantially Equivalent on May 18, 1988, 37 days after the submission was received.
What is the product code of K881501?
The FDA product code is JSX – Kit, Identification, Neisseria Gonorrhoeae, a Class I (low risk) device regulated under 21 CFR 866.2660.