The following data is part of a premarket notification filed by Antibodies Inc. with the FDA for Nephelrate Antiserums 1ga.
| Device ID | K781655 |
| 510k Number | K781655 |
| Device Name: | NEPHELRATE ANTISERUMS 1GA |
| 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 |