510(k) K915348
K915348 is an FDA 510(k) premarket notification submitted by Pharmacia Diagnostics, Inc. for the device "EBV-VCA IGM ELISA". The FDA issued a decision of Substantially Equivalent on February 14, 1992. The device falls under product code LJN (Antibody Igm, If, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Pharmacia Diagnostics, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 1992
- Date Received
- November 26, 1991
- 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