The following data is part of a premarket notification filed by Polymedco, Inc. with the FDA for Test, Rheumatoid Factor.
| Device ID | K955086 |
| 510k Number | K955086 |
| Device Name: | TEST, RHEUMATOID FACTOR |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | POLYMEDCO, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Contact | Frank J Coviello |
| Correspondent | Frank J Coviello POLYMEDCO, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-07 |
| Decision Date | 1995-12-20 |