LIQUICHEK CARDIAC MARKER CONTROL LT

Multi-analyte Controls, All Kinds (assayed)

BIO-RAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Liquichek Cardiac Marker Control Lt.

Pre-market Notification Details

Device IDK040277
510k NumberK040277
Device Name:LIQUICHEK CARDIAC MARKER CONTROL LT
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD. Irvine,  CA  92618 -2017
ContactMaria Zeballos
CorrespondentMaria Zeballos
BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD. Irvine,  CA  92618 -2017
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-02-05
Decision Date2004-03-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847661002123 K040277 000
00847661001911 K040277 000
00847661000693 K040277 000
00847661000686 K040277 000
00847661000679 K040277 000
00847661000662 K040277 000
00847661000655 K040277 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.