The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Anti-dsdna Control, Model 213.
Device ID | K984396 |
510k Number | K984396 |
Device Name: | LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 |
Classification | Anti-dna Antibody (enzyme-labeled), Antigen, 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 | LRM |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-12-09 |
Decision Date | 1998-12-18 |
Summary: | summary |