Goat Anti-Influenza Antisera
FDA 510(k) K780007 · Northeast Biomedical Labs., Inc.
510(k) numberK780007
Submission
- Device name
- Goat Anti-Influenza Antisera
- Applicant
- Northeast Biomedical Labs., Inc.
Mchenry, IL, US - Received
- January 3, 1978
- Decision date
- January 20, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GQQ – Antisera, Hai, Parainfluenza Virus 1-4
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3400
- Specialty
- Microbiology
More from Northeast Biomedical Labs., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K780697 | Goat Anti-Influenza Antisera AtexasGNS · Traditional | 05/03/1978SE |
| K780696 | Goat Antiinfluenza Antisera AussrGNS · Traditional | 05/03/1978SE |
| K780010 | Goat Anti-Rubella AntiseraGOK · Traditional | 01/20/1978SE |
| K780009 | Guinea Pig Whole SerumKIS · Traditional | 01/20/1978SE |
| K780008 | Goat Anti-Influenza AntiseraGQT · Traditional | 01/20/1978SE |
| K780006 | Goat Anti-Influenza AntiseraGNS · Traditional | 01/20/1978SE |
| K780005 | Goat Anti-Influenza AntiseraGNS · Traditional | 01/20/1978SE |
| K780004 | Goat Anti-Influenza AntiseraGNS · Traditional | 01/20/1978SE |
Questions and answers
When was Goat Anti-Influenza Antisera cleared by the FDA?
Goat Anti-Influenza Antisera (K780007) received a 510(k) decision of Substantially Equivalent on January 20, 1978, 17 days after the submission was received.
What is the product code of K780007?
The FDA product code is GQQ – Antisera, Hai, Parainfluenza Virus 1-4, a Class I (low risk) device regulated under 21 CFR 866.3400.