CLEARBLUE EASY PREGNANCY TEST

Kit, Test, Pregnancy, Hcg, Over The Counter

SPD DEVELOPMENT COMPANY LIMITED

The following data is part of a premarket notification filed by Spd Development Company Limited with the FDA for Clearblue Easy Pregnancy Test.

Pre-market Notification Details

Device IDK110433
510k NumberK110433
Device Name:CLEARBLUE EASY PREGNANCY TEST
ClassificationKit, Test, Pregnancy, Hcg, Over The Counter
Applicant SPD DEVELOPMENT COMPANY LIMITED STANNARD WAY PRIORY BUSINESS PARK Bedford, Bedfordshire,  GB Mk44 3up
ContactTanya Fair
CorrespondentTanya Fair
SPD DEVELOPMENT COMPANY LIMITED STANNARD WAY PRIORY BUSINESS PARK Bedford, Bedfordshire,  GB Mk44 3up
Product CodeLCX  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-15
Decision Date2011-05-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10633472601023 K110433 000
00633472322587 K110433 000
00633472249631 K110433 000
00633472222788 K110433 000
10633472601849 K110433 000
10633472601719 K110433 000
10633472602235 K110433 000

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