PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II

Assay, Glycosylated Hemoglobin

PRIMUS CORP.

The following data is part of a premarket notification filed by Primus Corp. with the FDA for Primus Liquid Control For Ghb/alc Level I And Level Ii.

Pre-market Notification Details

Device IDK992921
510k NumberK992921
Device Name:PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II
ClassificationAssay, Glycosylated Hemoglobin
Applicant PRIMUS CORP. P.O. BOX 22599 Kansas City,  MO  64113
ContactJimmie K Noffsinger
CorrespondentJimmie K Noffsinger
PRIMUS CORP. P.O. BOX 22599 Kansas City,  MO  64113
Product CodeLCP  
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-30
Decision Date1999-11-12
Summary:summary

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