510(k) K875204
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