The following data is part of a premarket notification filed by Northeast Biomedical Labs., Inc. with the FDA for Goat Anti-influenza Antisera.
Device ID | K780008 |
510k Number | K780008 |
Device Name: | GOAT ANTI-INFLUENZA ANTISERA |
Classification | Antisera, Cf, Parainfluenza Virus 1-4 |
Applicant | NORTHEAST BIOMEDICAL LABS., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GQT |
CFR Regulation Number | 866.3400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-01-03 |
Decision Date | 1978-01-20 |