The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Liquidchek Cardiac Markers Plus Control Lt; Level 1c, Level 2, Level 3, Trilevel Minipak.
Device ID | K123663 |
510k Number | K123663 |
Device Name: | LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | Bio-Rad Laboratories 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
Contact | Suzanne Parsons |
Correspondent | Suzanne Parsons Bio-Rad Laboratories 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-11-28 |
Decision Date | 2012-12-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847661004165 | K123663 | 000 |
00847661004158 | K123663 | 000 |
00847661004141 | K123663 | 000 |
00847661004134 | K123663 | 000 |