THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE
FDA 510(k) clearance K871105 · decided 1987-05-13
Clearance details
- K-number
- K871105
- Device name
- THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE
- Applicant
- New Horizons Diagnostics Co.
- Decision
- Substantially Equivalent
- Date received
- 1987-03-19
- Decision date
- 1987-05-13
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- LIC
- Device class
- 2
- Regulation number
- 866.3390
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Columbia, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PHADEBACT MONOCLONAL GC TEST, MODIFICATION (K921075) | Karo Bio Diagnostics AB | 1992-05-22 |
| IDEIA(TM) CHLAMYDIA, MODIFICATION (K911430) | Novo Nordisk Diagnostics, Ltd. | 1991-08-07 |
| G-MARK (K880076) | Bainbridge Laboratories, Inc. | 1988-07-01 |
| MERITEC(TM)-GC (K874078) | Meridian Diagnostics, Inc. | 1987-12-09 |
| PHADEBACT MONOCLONAL GC OMNI TEST (K851650) | Pharmacia, Inc. | 1985-07-12 |
| PHADEBACT MONOCLONAL GC TEST (K850351) | Pharmacia, Inc. | 1985-03-13 |
| IMPROVED GONO GEN (K821362) | New Horizons Diagnostics Co. | 1982-08-04 |
| NEISSERIA GONORRHOEAE TEST (K820007) | New Horizons Diagnostics Co. | 1982-01-29 |
Recalls involving this device
No recalls on record reference this clearance.