The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Antibody To Mumps Virus Ifa Test.
| Device ID | K822826 |
| 510k Number | K822826 |
| Device Name: | ANTIBODY TO MUMPS VIRUS IFA TEST |
| Classification | Antiserum, Fluorescent, Mumps Virus |
| Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GRA |
| CFR Regulation Number | 866.3380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-21 |
| Decision Date | 1982-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G5229032011 | K822826 | 000 |
| G5229032001 | K822826 | 000 |