Ideia(Tm) Chlamydia, Modification
FDA 510(k) K911430 · Novo Nordisk Diagnostics, Ltd.
510(k) numberK911430
Submission
- Device name
- Ideia(Tm) Chlamydia, Modification
- Applicant
- Novo Nordisk Diagnostics, Ltd.
Cambridge Cb4 4ws England, GB - Received
- March 28, 1991
- Decision date
- August 7, 1991
- 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 |
| 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 |
| K821362 | Improved Gono GenLIC · Traditional | New Horizons Diagnostics Co. | 08/04/1982SE |
| K820007 | Neisseria Gonorrhoeae TestLIC · Traditional | New Horizons Diagnostics Co. | 01/29/1982SE |
More from New Horizons Diagnostics Co.
| 510(k) | Device | Decision |
|---|---|---|
| K901972 | Add'L Claimed Intended Use for Ideia(Tm) ChlamydiaLJC · Traditional | 09/05/1990SE |
Questions and answers
When was Ideia(Tm) Chlamydia, Modification cleared by the FDA?
Ideia(Tm) Chlamydia, Modification (K911430) received a 510(k) decision of Substantially Equivalent on August 7, 1991, 132 days after the submission was received.
What is the product code of K911430?
The FDA product code is LIC – Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae, a Class II (moderate risk) device regulated under 21 CFR 866.3390.