510(k) K780008
K780008 is an FDA 510(k) premarket notification submitted by Northeast Biomedical Labs., Inc. for the device "GOAT ANTI-INFLUENZA ANTISERA". The FDA issued a decision of Substantially Equivalent on January 20, 1978. The device falls under product code GQT (Antisera, Cf, Parainfluenza Virus 1-4), a Class I device regulated under 21 CFR 866.3400. Northeast Biomedical Labs., Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 20, 1978
- Date Received
- January 3, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Cf, Parainfluenza Virus 1-4
- Device Class
- Class I
- Regulation Number
- 866.3400
- Review Panel
- MI
- Submission Type