GOAT ANTI-INFLUENZA ANTISERA
FDA 510(k) clearance K780007 · decided 1978-01-20
Clearance details
- K-number
- K780007
- Device name
- GOAT ANTI-INFLUENZA ANTISERA
- Applicant
- Northeast Biomedical Labs., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-01-03
- Decision date
- 1978-01-20
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- GQQ
- Device class
- 1
- Regulation number
- 866.3400
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.