510(k) K900546
K900546 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT". The FDA issued a decision of Substantially Equivalent on Jun 15, 1990. 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. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 15, 1990
- Date Received
- Feb 5, 1990
- 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)