The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Rheumatoid Factor (rf).
| Device ID | K024067 |
| 510k Number | K024067 |
| Device Name: | RHEUMATOID FACTOR (RF) |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | ABBOTT LABORATORIES 1920 HURD DR. Irving, TX 75038 |
| Contact | Linda Morris |
| Correspondent | Linda Morris ABBOTT LABORATORIES 1920 HURD DR. Irving, TX 75038 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-10 |
| Decision Date | 2003-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740028473 | K024067 | 000 |