The following data is part of a premarket notification filed by Antibodies Inc. with the FDA for Nephelrate Antiperums Lgm.
Device ID | K781654 |
510k Number | K781654 |
Device Name: | NEPHELRATE ANTIPERUMS LGM |
Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
Applicant | ANTIBODIES INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CFN |
CFR Regulation Number | 866.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-09-27 |
Decision Date | 1978-11-08 |