510(k) K800328
K800328 is an FDA 510(k) premarket notification submitted by Clinical Sciences, Inc. for the device "NEISSERIA GONORRHOEAE FLUORO-KIT". The FDA issued a decision of Substantially Equivalent on Mar 3, 1980. The device falls under product code GTH (Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae), a Class II device regulated under 21 CFR 866.3390. Clinical Sciences, Inc. has 29 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 3, 1980
- Date Received
- Feb 12, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae
- Device Class
- Class II
- Regulation Number
- 866.3390
- Review Panel
- MI
- Submission Type
- 510(k)