510(k) K910042
K910042 is an FDA 510(k) premarket notification submitted by Gull Laboratories, Inc. for the device "EBV IGM ELISA TEST". The FDA issued a decision of Substantially Equivalent on February 21, 1991. The device falls under product code LJN (Antibody Igm, If, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Gull Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 1991
- Date Received
- January 4, 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