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 |