The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Eni Antibody To Measles(rubeola) Virus.
| Device ID | K821249 |
| 510k Number | K821249 |
| Device Name: | ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS |
| Classification | Antiserum, Fluorescent, Rubeola |
| Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GRE |
| CFR Regulation Number | 866.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-30 |
| Decision Date | 1982-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G5229031011 | K821249 | 000 |
| G5229031001 | K821249 | 000 |