The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Anti-sm Control, Eia, Model 208.
| Device ID | K984479 |
| 510k Number | K984479 |
| Device Name: | LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 |
| Classification | Anti-sm Antibody, Antigen And Control |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 |
| Contact | Elizabeth Platt |
| Correspondent | Elizabeth Platt BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 |
| Product Code | LKP |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-16 |
| Decision Date | 1998-12-22 |
| Summary: | summary |