510(k) K840509
K840509 is an FDA 510(k) premarket notification submitted by Scientific Device Laboratory, Inc. for the device "NEISSERIA MENINGITIDIS GR. B". The FDA issued a decision of Substantially Equivalent on Mar 23, 1984. The device falls under product code LSC (Neisseria Controls), a Class I device regulated under 21 CFR 866.2660. Scientific Device Laboratory, Inc. has 27 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 23, 1984
- Date Received
- Feb 6, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Neisseria Controls
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type
- 510(k) Exempt