The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Rheumatoid Factor Latex Slide Test Kit.
| Device ID | K961169 |
| 510k Number | K961169 |
| Device Name: | RHEUMATOID FACTOR LATEX SLIDE TEST KIT |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Contact | P. Armstrong |
| Correspondent | P. Armstrong RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-25 |
| Decision Date | 1996-06-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273205046 | K961169 | 000 |
| 05055273205022 | K961169 | 000 |