The following data is part of a premarket notification filed by Antibodies Inc. with the FDA for Nephelrate Antiserums C3c.
Device ID | K781653 |
510k Number | K781653 |
Device Name: | NEPHELRATE ANTISERUMS C3C |
Classification | Complement C3, Antigen, Antiserum, Control |
Applicant | ANTIBODIES INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CZW |
CFR Regulation Number | 866.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-09-27 |
Decision Date | 1978-11-08 |