The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Optimate Igm Test.
| Device ID | K841814 |
| 510k Number | K841814 |
| Device Name: | OPTIMATE IGM TEST |
| Classification | Igm, Antigen, Antiserum, Control |
| Applicant | MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DFT |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-01 |
| Decision Date | 1984-06-22 |