The following data is part of a premarket notification filed by Immunostics Co., Inc. with the FDA for Immuno Ra Undiluted.
| Device ID | K926569 |
| 510k Number | K926569 |
| Device Name: | IMMUNO RA UNDILUTED |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | IMMUNOSTICS CO., INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Contact | Kupits |
| Correspondent | Kupits IMMUNOSTICS CO., INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-31 |
| Decision Date | 1993-04-06 |