Improved Gono Gen
FDA 510(k) K821362 · New Horizons Diagnostics Co.
510(k) numberK821362
Submission
- Device name
- Improved Gono Gen
- Applicant
- New Horizons Diagnostics Co.
- Received
- May 7, 1982
- Decision date
- August 4, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIC – Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3390
- Specialty
- Microbiology
Other 510(k)s with product code LIC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K921075 | Phadebact Monoclonal GC Test, ModificationLIC · Traditional | Karo Bio Diagnostics AB | 05/22/1992SE |
| K911430 | Ideia(Tm) Chlamydia, ModificationLIC · Traditional | Novo Nordisk Diagnostics, Ltd. | 08/07/1991SE |
| K880076 | G-MarkLIC · Traditional | Bainbridge Laboratories, Inc. | 07/01/1988SE |
| K874078 | Meritec(Tm)-GcLIC · Traditional | Meridian Diagnostics, Inc. | 12/09/1987SE |
| K871105 | The Gonogen II Test Kit for Neisseria GonorrhoeaeLIC · Traditional | New Horizons Diagnostics Co. | 05/13/1987SE |
| K851650 | Phadebact Monoclonal GC Omni TestLIC · Traditional | Pharmacia, Inc. | 07/12/1985SE |
| K850351 | Phadebact Monoclonal GC TestLIC · Traditional | Pharmacia, Inc. | 03/13/1985SE |
| K820007 | Neisseria Gonorrhoeae TestLIC · Traditional | New Horizons Diagnostics Co. | 01/29/1982SE |
More from New Horizons Diagnostics Co.
| 510(k) | Device | Decision |
|---|---|---|
| K932622 | Cholera Smart(Tm)GSQ · Traditional | 06/27/1995SE |
| K925190 | PyloriscreenLYR · Traditional | 03/23/1993SE |
| K922432 | CholerascreenGSQ · Traditional | 12/07/1992SE |
| K874761 | Rapid Colorimetric Direct Strep a TestGTZ · Traditional | 02/19/1988SE |
| K871226 | Syphilis Serological ReagentsGMQ · Traditional | 05/28/1987SE |
| K871105 | The Gonogen II Test Kit for Neisseria GonorrhoeaeLIC · Traditional | 05/13/1987SE |
| K862195 | Rapid Bacteriuria Screen (RBS)JXA · Traditional | 06/30/1986SE |
| K851132 | Latex Agglutination TestGTZ · Traditional | 07/05/1985SE |
| K820007 | Neisseria Gonorrhoeae TestLIC · Traditional | 01/29/1982SE |
Questions and answers
When was Improved Gono Gen cleared by the FDA?
Improved Gono Gen (K821362) received a 510(k) decision of Substantially Equivalent on August 4, 1982, 89 days after the submission was received.
What is the product code of K821362?
The FDA product code is LIC – Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae, a Class II (moderate risk) device regulated under 21 CFR 866.3390.