510(k) K872881
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