510(k) K820192
K820192 is an FDA 510(k) premarket notification submitted by Hyland Therapeutic Div., Travenol Laboratories for the device "HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM". The FDA issued a decision of Substantially Equivalent on March 11, 1982. The device falls under product code GRP (Antisera, All Types, H. Influenza), a Class II device regulated under 21 CFR 866.3300. Hyland Therapeutic Div., Travenol Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 1982
- Date Received
- January 25, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, All Types, H. Influenza
- Device Class
- Class II
- Regulation Number
- 866.3300
- Review Panel
- MI
- Submission Type