510(k) K875204

DU PONT VCA-IGM ANTIBODY ELISA KIT by E.I. Dupont DE Nemours & Co., Inc. — Product Code LJN

K875204 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DU PONT VCA-IGM ANTIBODY ELISA KIT". The FDA issued a decision of Substantially Equivalent on July 8, 1988. The device falls under product code LJN (Antibody Igm, If, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1988
Date Received
December 18, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antibody Igm, If, Epstein-Barr Virus
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type