The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Latest Rf Kit For Rheumatoid Factor.
| Device ID | K822905 |
| 510k Number | K822905 |
| Device Name: | LATEST RF KIT FOR RHEUMATOID FACTOR |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | FISHER SCIENTIFIC CO., LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-29 |
| Decision Date | 1982-10-18 |