The following data is part of a premarket notification filed by Gilford with the FDA for Gilford Immunoglobulin M Reagent.
| Device ID | K853469 |
| 510k Number | K853469 |
| Device Name: | GILFORD IMMUNOGLOBULIN M REAGENT |
| Classification | Igm, Antigen, Antiserum, Control |
| Applicant | GILFORD 132 ARTINO ST. Oberlin, OH 44974 |
| Contact | Craig H Reason |
| Correspondent | Craig H Reason GILFORD 132 ARTINO ST. Oberlin, OH 44974 |
| Product Code | DFT |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-19 |
| Decision Date | 1985-09-16 |