510(k) K810043
K810043 is an FDA 510(k) premarket notification submitted by Vibac Corp. for the device "GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I". The FDA issued a decision of Substantially Equivalent on May 15, 1981. The device falls under product code GQM (Antisera, Neutralization, Herpesvirus Hominis), a Class II device regulated under 21 CFR 866.3305.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 1981
- Date Received
- January 7, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Neutralization, Herpesvirus Hominis
- Device Class
- Class II
- Regulation Number
- 866.3305
- Review Panel
- MI
- Submission Type