LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220

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 Maternal Serum Control, Model 220.

Pre-market Notification Details

Device IDK984594
510k NumberK984594
Device Name:LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220
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 Received1998-12-28
Decision Date1999-02-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847661001751 K984594 000
00847661001263 K984594 000

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