The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Antibody To Respiratory Syncytial Virus.
| Device ID | K831924 |
| 510k Number | K831924 |
| Device Name: | ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS |
| Classification | Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
| Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LKT |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-15 |
| Decision Date | 1983-08-11 |