510(k) K782013
K782013 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "GONO-CELL". The FDA issued a decision of Substantially Equivalent on Apr 23, 1979. The device falls under product code JSX (Kit, Identification, Neisseria Gonorrhoeae), a Class I device regulated under 21 CFR 866.2660. Abbott Laboratories has 889 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 23, 1979
- Date Received
- Dec 5, 1978
- 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