LYPHOCHEK ANEMIA CONTROL, MODEL 500

Multi-analyte Controls, All Kinds (assayed)

BIO-RAD

The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphochek Anemia Control, Model 500.

Pre-market Notification Details

Device IDK992741
510k NumberK992741
Device Name:LYPHOCHEK ANEMIA CONTROL, MODEL 500
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant BIO-RAD 9500 JERONIMO RD. Irvine,  CA  92618 -2017
ContactElizabeth Platt
CorrespondentElizabeth Platt
BIO-RAD 9500 JERONIMO RD. Irvine,  CA  92618 -2017
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-16
Decision Date1999-11-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847661002086 K992741 000
00847661000891 K992741 000

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