The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Rheumatoid Factor Latex-enhanced Immunoturbidimetric Test Kit.
| Device ID | K972220 |
| 510k Number | K972220 |
| Device Name: | RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, Co. Antrim, IE Bt29 4qy |
| Contact | P. Armstrong |
| Correspondent | P. Armstrong RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, Co. Antrim, 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 | 1997-06-12 |
| Decision Date | 1997-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414595603 | K972220 | 000 |
| 00630414482385 | K972220 | 000 |
| 05055273205084 | K972220 | 000 |
| 05055273205077 | K972220 | 000 |
| 05055273205060 | K972220 | 000 |
| 05055273205053 | K972220 | 000 |
| 05055273205039 | K972220 | 000 |