The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Cardiac Markers Control Lt Level 1, 2, 3, And Trilevel.
Device ID | K021498 |
510k Number | K021498 |
Device Name: | LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL |
Classification | Enzyme Controls (assayed And Unassayed) |
Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 |
Contact | Maria Zeballos |
Correspondent | Maria Zeballos BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 |
Product Code | JJT |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-09 |
Decision Date | 2002-05-24 |
Summary: | summary |