The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Rheumatoid Factor Control.
| Device ID | K960987 |
| 510k Number | K960987 |
| Device Name: | LIQUICHEK RHEUMATOID FACTOR CONTROL |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | BIO-RAD 3726 EAST MIRALOMA AVE. Anaheim, CA 92806 |
| Contact | Elizabeth Platt |
| Correspondent | Elizabeth Platt BIO-RAD 3726 EAST MIRALOMA AVE. Anaheim, CA 92806 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-11 |
| Decision Date | 1996-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661001836 | K960987 | 000 |
| 00847661001515 | K960987 | 000 |
| 00847661001508 | K960987 | 000 |
| 00847661001492 | K960987 | 000 |