FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GOAT ANTI-INFLUENZA ANTISERA
K Number: K780007
·
Decision Jan 20, 1978
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
9
Review Days
17
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Basic Information
- Device Name
- GOAT ANTI-INFLUENZA ANTISERA
- K Number
- K780007
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3400
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Northeast Biomedical Labs., Inc.
- Date Received
- January 3, 1978
- Decision Date
- January 20, 1978
- Product Code
- GQQ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GQQ | Antisera, Hai, Parainfluenza Virus 1-4 | FDA class 1 | Microbiology |
Other Clearances by Northeast Biomedical Labs., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K780696 | GOAT ANTIINFLUENZA ANTISERA AUSSR | May 3, 1978 | Substantially Equivalent |
| K780697 | GOAT ANTI-INFLUENZA ANTISERA ATEXAS | May 3, 1978 | Substantially Equivalent |
| K780009 | GUINEA PIG WHOLE SERUM | Jan 20, 1978 | Substantially Equivalent |
| K780005 | GOAT ANTI-INFLUENZA ANTISERA | Jan 20, 1978 | Substantially Equivalent |
| K780010 | GOAT ANTI-RUBELLA ANTISERA | Jan 20, 1978 | Substantially Equivalent |
| K780006 | GOAT ANTI-INFLUENZA ANTISERA | Jan 20, 1978 | Substantially Equivalent |
| K780008 | GOAT ANTI-INFLUENZA ANTISERA | Jan 20, 1978 | Substantially Equivalent |
| K780004 | GOAT ANTI-INFLUENZA ANTISERA | Jan 20, 1978 | Substantially Equivalent |