QUANTECH TOTAL B-HCG ASSAY

Test, Immunoassay, Biosensor, Hcg

QUANTECH LTD.

The following data is part of a premarket notification filed by Quantech Ltd. with the FDA for Quantech Total B-hcg Assay.

Pre-market Notification Details

Device IDK990258
510k NumberK990258
Device Name:QUANTECH TOTAL B-HCG ASSAY
ClassificationTest, Immunoassay, Biosensor, Hcg
Applicant QUANTECH LTD. 9418 LASAINE AVE. Northridge,  CA  91325
ContactRobin Hellen
CorrespondentRobin Hellen
QUANTECH LTD. 9418 LASAINE AVE. Northridge,  CA  91325
Product CodeNAL  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-01-27
Decision Date1999-12-21
Summary:summary

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