510(k) K872881

ABBOTT CMV-M EIA KIT by Abbott Laboratories — Product Code LKQ

K872881 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT CMV-M EIA KIT". The FDA issued a decision of Substantially Equivalent on May 13, 1988. The device falls under product code LKQ (Antibody Igm,If, Cytomegalovirus Virus), a Class II device regulated under 21 CFR 866.3175. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1988
Date Received
July 22, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antibody Igm,If, Cytomegalovirus Virus
Device Class
Class II
Regulation Number
866.3175
Review Panel
MI
Submission Type