510(k) K840514

NEISSERIA MENINGITIDIS CONTROL by Scientific Device Laboratory, Inc. — Product Code LSC

K840514 is an FDA 510(k) premarket notification submitted by Scientific Device Laboratory, Inc. for the device "NEISSERIA MENINGITIDIS CONTROL". The FDA issued a decision of Substantially Equivalent on March 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 at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1984
Date Received
February 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