510(k) K780010
K780010 is an FDA 510(k) premarket notification submitted by Northeast Biomedical Labs., Inc. for the device "GOAT ANTI-RUBELLA ANTISERA". The FDA issued a decision of Substantially Equivalent on January 20, 1978. The device falls under product code GOK (Antisera, Hai (Including Hai Control), Rubella), a Class II device regulated under 21 CFR 866.3510. 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, Hai (Including Hai Control), Rubella
- Device Class
- Class II
- Regulation Number
- 866.3510
- Review Panel
- MI
- Submission Type