The following data is part of a premarket notification filed by Meloy Laboratories, Inc. with the FDA for Meloy Autoantibody Test Sys.
| Device ID | K842247 |
| 510k Number | K842247 |
| Device Name: | MELOY AUTOANTIBODY TEST SYS |
| Classification | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | MELOY LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DBM |
| CFR Regulation Number | 866.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-06 |
| Decision Date | 1984-06-26 |