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SPD SWISS PRECISION DIAGNOSTICS GMBH

Matched from indexed company URL: Spd Swiss Precision Diagnostics GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30066353203006635320SPD SWISS PRECISION DIAGNOSTICS GMBH1N2026-01-01C O PROCTER & GAMBLE 47 ROUTE DE SAINT GEORGES PETIT LANCY, GENEVA Geneve CH 1213 CH

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00381519194696Clearblue - The Clearblue Period Cycle Tracker App is a free mobile phone app which uses the mobile phone’s camera to capture the result of compatible lateral flow test strips, such as the Clearblue Smart Ovulation Test (SOT). The test sticks and the app work as a system.1-800-899-7353xx@xx.xx
00633472600760Clearblue - CBDOT Clearblue Ovulation Digital 10ct1-800-321-3279xx@xx.xx
00633472601156Clearblue - A convenience kit consisting of 1 Clearblue Pregnancy Test with Smart Countdown device and 1 Clearblue Rapid Detection Pregnancy Test devices800-321-3279xx@xx.xx
00633472602313Clearblue - Clearblue Preg Dig CB15 5ct - US1-800-321-3279xx@xx.xx
00633472602559Clearblue - CLEARBLUE OVUL SOT 10CT US1-800-321-3279xx@xx.xx
00633472602566Clearblue - CLEARBLUE OVUL SOT 20CT US1-800-321-3279xx@xx.xx
00633472602573Clearblue - CLEARBLUE OVUL SOT 50CT US1-800-321-3279xx@xx.xx
00633472602603Clearblue - CLEARBLUE PREG VIS CB16 1CT TRAY US800 321 3279xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
261581901456812K993483ACON ONE STEP HOME PREGNANCY TEST STRIPLCX2000-01-20
261581713390625K991466EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)CEP1999-05-25
261581440456364K983090ACON MIDSTREAM PREGNANCY TESTLCX1998-11-18
261581657454168K981271CLEARPLAN EASY OVULATION TESTCEP1998-06-25
261581999720863K981207CLEARPLAN EASY FERTILITY MONITORNGE1998-10-28
261581725357834K213379Clearblue ® Early Pregnancy TestLCX2022-09-21
261581902771578K210341One Step Pregnancy TestLCX2022-03-10
261581634910735K200913Clearblue® Early Digital Pregnancy TestLCX2021-08-13
261581173237996K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)JHI2017-12-22
261581218667948K110433CLEARBLUE EASY PREGNANCY TESTLCX2011-05-12
261581428733720K061769E.P.T. CERTAINTY 1-STEP PREGNANCY TESTLCX2006-07-03
261581189705454K060128CLEARBLUE EASY DIGITAL PREGNANCY TESTLCX2006-05-25
261581236053322K050546ACON +/- MIDSTREAM PREGNANCY TESTLCX2005-05-20
261581392751578K042280FACT PLUS ONE-STEP PREGNANCY TEST KITLCX2004-09-10
261582015354042K040341CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TESTLCX2004-03-08
261581438934380K040329MODIFICATION TO E.P.T. PREGNANCY TESTLCX2004-03-08
261581252274462K030659CLEARBLUE EASY DIGITAL PREGNANCY TESTLCX2003-05-02
261581366664717K013907INVERNESS MEDICAL EARLY PREGNANCY TESTLCX2001-12-18
261581865953544K012252QUIK-CHECK OVULATION PREDICTORCEP2001-08-24
261581691564736K012215QUIK-CHECK HOME PREGNANCY TESTLCX2001-08-07
261581805138625K002867INVERNESS MEDICAL OVULATION PREDICTOR TESTCEP2000-10-12
261582031020375K002049INVERNESS MEDICAL EARLY PREGNANCY TESTLCX2000-07-27
261581218849528
261581532570064
261581815181137

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LCX232022-09-21
CEP52001-08-24
NGE21998-10-28
JHI12017-12-22

PMN#

GUDID#

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