Neisseria - Kwik Plus
FDA 510(k) K852998 · Micro-Bio-Logics
510(k) numberK852998
Submission
- Device name
- Neisseria - Kwik Plus
- Applicant
- Micro-Bio-Logics
St. Cloud, MN, US - Received
- July 15, 1985
- Decision date
- July 23, 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 |
| 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 |
|---|---|---|
| K870731 | Lyfo Kwik(Tm) Rus KitJXA · Traditional | 06/17/1987SE |
| K861312 | Lyfo-Kwik (TM) Coagulase PlasmaJTL · Traditional | 04/18/1986SE |
| K861022 | Kwik Stik(Tm) Lyfo(Tm) Disk MicroorganismsJTR · Traditional | 04/04/1986SE |
| K855172 | Kwi (TM) G-Co/TwoJSK · Traditional | 02/20/1986SE |
| K855198 | Indi Kwik (TM) Co/Two KitJTR · Traditional | 01/14/1986SE |
| K851978 | Lyfo-Kwik Omi KitJSS · Traditional | 06/04/1985SE |
| K844014 | Ono/Co-Two (TM) SystemsJTY · Traditional | 10/31/1984SE |
| K842129 | Lyfo-Disk MicroorganismsJTR · Traditional | 07/03/1984SE |
Questions and answers
When was Neisseria - Kwik Plus cleared by the FDA?
Neisseria - Kwik Plus (K852998) received a 510(k) decision of Substantially Equivalent on July 23, 1985, 8 days after the submission was received.
What is the product code of K852998?
The FDA product code is JSX – Kit, Identification, Neisseria Gonorrhoeae, a Class I (low risk) device regulated under 21 CFR 866.2660.