510(k) K880511
K880511 is an FDA 510(k) premarket notification submitted by Austin Biological Laboratories for the device "XACT NEISSERIA". The FDA issued a decision of Substantially Equivalent on Aug 25, 1988. The device falls under product code JSX (Kit, Identification, Neisseria Gonorrhoeae), a Class I device regulated under 21 CFR 866.2660. Austin Biological Laboratories has 44 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 25, 1988
- Date Received
- Feb 9, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Kit, Identification, Neisseria Gonorrhoeae
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type
- 510(k) Exempt