NEISSERIA GONORRHOEAE FLUORO-KIT
FDA 510(k) clearance K800328 · decided 1980-03-03
Clearance details
- K-number
- K800328
- Device name
- NEISSERIA GONORRHOEAE FLUORO-KIT
- Applicant
- Clinical Sciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-02-12
- Decision date
- 1980-03-03
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- GTH
- Device class
- 2
- Regulation number
- 866.3390
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT (K900546) | Baxter Healthcare Corp | 1990-06-15 |
| MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST (K861835) | Syva Co. | 1986-05-29 |
Recalls involving this device
No recalls on record reference this clearance.