LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK

Drug Mixture Control Materials

BIO-RAD

The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Qualitative Urine Toxicology Control, Negative, Positive, Minipak.

Pre-market Notification Details

Device IDK052053
510k NumberK052053
Device Name:LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK
ClassificationDrug Mixture Control Materials
Applicant BIO-RAD 9500 JERONIMO RD. Irvine,  CA  92618 -2017
ContactSuzanne S Parsons
CorrespondentSuzanne S Parsons
BIO-RAD 9500 JERONIMO RD. Irvine,  CA  92618 -2017
Product CodeDIF  
CFR Regulation Number862.3280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-29
Decision Date2005-08-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847661002048 K052053 000
00847661001621 K052053 000
00847661001614 K052053 000

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