The following data is part of a premarket notification filed by Meloy Laboratories, Inc. with the FDA for Anti-ena Test.
| Device ID | K831292 |
| 510k Number | K831292 |
| Device Name: | ANTI-ENA TEST |
| Classification | Anti-rnp Antibody, Antigen And Control |
| Applicant | MELOY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LKO |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-20 |
| Decision Date | 1983-07-18 |