LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL

Multi-analyte Controls, All Kinds (assayed)

Bio-Rad Laboratories

The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Lypochek Specialty Immunoassay Control.

Pre-market Notification Details

Device IDK133960
510k NumberK133960
Device Name:LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant Bio-Rad Laboratories 9500 JERONIMO RD. Irvine,  CA  92618 -2017
ContactSuzanne Parsons
CorrespondentSuzanne Parsons
Bio-Rad Laboratories 9500 JERONIMO RD. Irvine,  CA  92618 -2017
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-24
Decision Date2014-01-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847661005681 K133960 000
00847661005674 K133960 000
00847661005667 K133960 000
00847661005650 K133960 000

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