The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Access Rubella Igg.
| Device ID | K954687 |
| 510k Number | K954687 |
| Device Name: | ACCESS RUBELLA IGG |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Carole Stamp |
| Correspondent | Carole Stamp BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-11 |
| Decision Date | 1996-04-09 |
| Summary: | summary |