Goni-Kit
FDA 510(k) K852582 · Culture Kits, Inc.
510(k) numberK852582
Submission
- Device name
- Goni-Kit
- Applicant
- Culture Kits, Inc.
Norwich, NY, US - Received
- June 18, 1985
- Decision date
- July 12, 1985
- 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 |
| K881501 | Modified Ids Rapid NH SystemJSX · Traditional | Innovative Diagnostic Systems, Inc. | 05/18/1988SE |
| 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 |
| 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 |
|---|---|---|
| K911846 | Uri-Three(Tm), ModificationJXA · Traditional | 10/04/1991SE |
| K854672 | Candi-Kit TMJSI · Traditional | 07/11/1986SE |
| K853488 | Staph KitJSI · Traditional | 08/28/1985SE |
| K851225 | Urine DuoJTZ · Traditional | 08/13/1985SE |
| K852480 | Derm-KitJSI · Traditional | 07/09/1985SE |
| K851518 | Mueller Hinton Sensitivity PlateJTZ · Traditional | 04/29/1985SE |
| K850765 | Strep-KitJSJ · Traditional | 04/24/1985SE |
| K850998 | Uri-KitJSG · Traditional | 04/01/1985SE |
Questions and answers
When was Goni-Kit cleared by the FDA?
Goni-Kit (K852582) received a 510(k) decision of Substantially Equivalent on July 12, 1985, 24 days after the submission was received.
What is the product code of K852582?
The FDA product code is JSX – Kit, Identification, Neisseria Gonorrhoeae, a Class I (low risk) device regulated under 21 CFR 866.2660.