LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563

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 Lyphochek Whole Blood Control, Models 561, 562, 563.

Pre-market Notification Details

Device IDK022041
510k NumberK022041
Device Name:LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563
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 Received2002-06-24
Decision Date2002-07-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847661001867 K022041 000
00847661001676 K022041 000
00847661001669 K022041 000
00847661001652 K022041 000

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