QUICKVUE ONE-STEP HCG-COMBO

Visual, Pregnancy Hcg, Prescription Use

QUIDEL CORP.

The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quickvue One-step Hcg-combo.

Pre-market Notification Details

Device IDK020801
510k NumberK020801
Device Name:QUICKVUE ONE-STEP HCG-COMBO
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant QUIDEL CORP. 10165 MCKELLAR CT. San Diego,  CA  92121
ContactJennifer S Hankard
CorrespondentJennifer S Hankard
QUIDEL CORP. 10165 MCKELLAR CT. San Diego,  CA  92121
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-12
Decision Date2002-05-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30014613201106 K020801 000

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