LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405

Heavy Metals Control Materials

BIO-RAD

The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphocheck Urine Metals Control, Item No.400, 405.

Pre-market Notification Details

Device IDK990928
510k NumberK990928
Device Name:LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405
ClassificationHeavy Metals Control Materials
Applicant BIO-RAD 9500 JERONIMO RD. Irvine,  CA  92618
ContactElizabeth Platt
CorrespondentElizabeth Platt
BIO-RAD 9500 JERONIMO RD. Irvine,  CA  92618
Product CodeDIE  
CFR Regulation Number862.3280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-19
Decision Date1999-04-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847661004073 K990928 000
00847661000297 K990928 000
00847661000280 K990928 000

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