Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006635320

FEI Number

3006635320

Entity Name

SPD SWISS PRECISION DIAGNOSTICS GMBH

City/State/Country

PETIT LANCY, GENEVA Geneve, CH

Establishment Address

C O PROCTER & GAMBLE, 47 ROUTE DE SAINT GEORGES, PETIT LANCY, GENEVA Geneve 1213 CH, CH

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

SPD SWISS PRECISION DIAGNOSTICS GMBH (Owner Number: 9102922)

Owner / Operator Contact Address

C/O PROCTER & GAMBLE, 47 ROUTE DE SAINT-GEORGES, PETIT-LANCY, GENEVA, CH-NOTA CH-1213, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210341

PMA Number

N/A

All Registered Proprietary Names

Clearblue Trying for a Baby Ovulation Kit Clearblue & Natural Cycles° Birth Control Kit Starter Pack Clearblue Advanced Digital Ovulation Test Kit Clearblue Trying for a Baby Advanced Ovulation Kit Clearblue Digital Ovulation Test Clearblue Smart Ovulation Test Clearblue Advanced Digital Ovulation Test Clearblue Period Cycle Tracker Clearblue Easy Ovulation Kit CVS Early Ovulation Test Kit TOPCARE HEALTH EARLY OVULATION TEST HEB EARLY OVULATION KIT TEST UP&UP EARLY OVULATION TEST EQUATE EARLY OVULATION TEST KROGER EARLY OVULATION TEST MEIJER CLEAR ANSWER EARLY OVULATION TEST Clearblue Digital Prueba de Embarazo Clearblue Advanced Digital Pregnancy Test Clearblue Early Detection Pregnancy Test Clearblue Digital & Rapid Detection Pregnancy Test Clearblue Advanced Fertility Monitor Clearblue Advanced Fertility Monitor Pregnancy Test Sticks Clearblue Pregnancy Test Digital Ultra Early Clearblue Rapid Detection Pregnancy Test Clearblue Flip & Click Pregnancy Test Clearblue Rapid & Digital Pregnancy Tests Clearblue Triple Assurance Pregnancy Tests Dollar General One Step Pregnancy Test CVP Health One Step Pregnancy Test CVS Health One Step Pregnancy Test CareOne One Step Pregnancy Test Equate One Step Pregnancy Test Signature Care One Step Pregnancy Test Equaline One Step Pregnancy Test TopCare Health One Step Pregnancy Test Walgreens One Step Pregnancy Test Clearblue Fertility Monitor Test Sticks Clearblue Fertility Monitor with Touch Screen CareOne Digital Wide-Tip Pregnancy Test Clearblue Digital Pregnancy Test HEB Digital Wide-Tip Pregnancy Test Kroger Digital Wide-Tip Pregnancy Test CVS HEALTH DIGITAL & ONE STEP PREGNANCY TEST KIT Signature Care Digital Pregnancy Test EQUATE DIGITAL PREGNANCY TEST CVS Health Digital & Early Result Pregnancy Test Kit Kroger Digital Pregnancy Test WALGREENS DIGITAL & EARLY RESULT PREGNANCY TESTS MEIJER CLEAR ANSWER DIGITAL PREGNANCY TEST MEIJER DIGITAL & EARLY RESULT PREGNANCY TEST CVS Health Digital Wide-Tip Pregnancy Test Amazon Digital Wide-Tip Pregnancy Test KROGER DIGITAL & ONE STEP PREGNANCY TEST Amazon Digital Pregnancy Test Equaline Digital Wide-Tip Pregnancy Test CVS HEALTH DIGITAL PREGNANCY TEST Signature Care Digital Wide-Tip Pregnancy Test TopCare Health Digital Wide-Tip Pregnancy Test Walgreens Digital Pregnancy Test CareOne Digital Wide-Tip Pregnancy Test Clearblue Digital Pregnancy Test HEB Digital Wide-Tip Pregnancy Test Kroger Digital Wide-Tip Pregnancy Test CVS HEALTH DIGITAL & ONE STEP PREGNANCY TEST KIT Signature Care Digital Pregnancy Test EQUATE DIGITAL PREGNANCY TEST CVS Health Digital & Early Result Pregnancy Test Kit Kroger Digital Pregnancy Test WALGREENS DIGITAL & EARLY RESULT PREGNANCY TESTS MEIJER CLEAR ANSWER DIGITAL PREGNANCY TEST MEIJER DIGITAL & EARLY RESULT PREGNANCY TEST CVS Health Digital Wide-Tip Pregnancy Test Amazon Digital Wide-Tip Pregnancy Test KROGER DIGITAL & ONE STEP PREGNANCY TEST Amazon Digital Pregnancy Test Equaline Digital Wide-Tip Pregnancy Test CVS HEALTH DIGITAL PREGNANCY TEST Signature Care Digital Wide-Tip Pregnancy Test TopCare Health Digital Wide-Tip Pregnancy Test Walgreens Digital Pregnancy Test Clearblue Digital Prueba de Embarazo Clearblue Advanced Digital Pregnancy Test Clearblue Early Detection Pregnancy Test Clearblue Digital & Rapid Detection Pregnancy Test Clearblue Advanced Fertility Monitor Clearblue Advanced Fertility Monitor Pregnancy Test Sticks Clearblue Pregnancy Test Digital Ultra Early TOPCARE HEALTH ONE STEP PREGNANCY TEST SIGNATURE CARE EARLY RESULT PREGNANCY TEST CVS HEALTH BILINGUAL EARLY RESULT PREGNANCY TEST EQUATE TRIPLE TEST PREGNANCY TEST KIT 7SELECT EARLY RESULT PREGNANCY TEST CVS HEALTH ADVANCED ONE STEP PREGNANCY TEST CAREONE EARLY RESULT PREGNANCY TEST ACCU-CLEAR PREGANCY TEST UP&UP ADVANCED EARLY RESULT PREGNANCY TEST SIGNATURE CARE ONE STEP PREGNANCY TEST MEIJER ADVANCED EARLY RESULT PREGNANCY TEST CVS HEALTH DIGITAL WIDE-TIP & ADVANCED ONE STEP PREGNANCY TESTS FIRST SIGNAL EARLY RESULT PREGNANCY TEST KROGER ADVANCED EARLY RESULT PREGNANCY TEST EQUALINE EARLY RESULT PREGNANCY TEST MEIJER CLEAR ANSWER ADVANCED ONE STEP PREGNANCY TEST WALGREENS TRIPLE TEST PREGNANCY TEST KIT KROGER ADVANCED ONE STEP +/- PREGNANCY TEST TOPCARE HEALTH EARLY RESULT PREGNANCY TEST DG Health One Step Pregnancy Test CVS HEALTH ONE STEP PREGNANCY TEST CVS TRIPLE TEST PREGNANCY TEST KIT Meijer Digital Wide-Tip & Early Result Pregnancy Tests EQUALINE ONE STEP PREGNANCY TEST Kroger Digital Wide-Tip & One Step Pregnancy Tests HEB ADVANCED ONE STEP PREGANCY TEST CVP Health One Step Pregnancy Test CAREONE ONE STEP PREGNANCY TEST Walgreens Digital & One Step Pregnancy Tests HEB ADVANCED EARLY RESULT PREGNANCY TEST WALGREENS EARLY RESULT PREGNANCY TEST WALGREENS ONE STEP PREGNANCY TEST HEB Digital Wide-Tip & Early Result Pregnancy Tests MEIJER CLEAR ANSWER ONE STEP PREGNANCY TEST AMAZON EARLY RESULT PREGNANCY TEST WALGREENS ADVANCED EARLY RESULT PREGNANCY TEST EQUATE ONE STEP PREGNANCY TEST CVS HEALTH DIGITAL WIDE-TIP & ADVANCED EARLY RESULT PREGNANCY TESTS MEIJER EARLY RESULT PREGNANCY TEST Rexall One Step Pregnancy Test CVS HEALTH EARLY RESULT PREGNANCY TEST WALGREENS ADVANCED ONE STEP PREGNANCY TEST Equate Advanced Early Result Pregnancy Test EXCHANGE SELECT ONE STEP PREGNANCY TEST FIRST SIGNAL ONE STEP PREGNANCY TEST Equate One Step Pregnancy Test H.E.B One-Step Cassette Pregnancy Test DG Health One Step Pregnancy Test Clearblue Easy Ovulation Kit CVS Early Ovulation Test Kit TOPCARE HEALTH EARLY OVULATION TEST HEB EARLY OVULATION KIT TEST UP&UP EARLY OVULATION TEST EQUATE EARLY OVULATION TEST KROGER EARLY OVULATION TEST MEIJER CLEAR ANSWER EARLY OVULATION TEST Dollar General One Step Pregnancy Test CVP Health One Step Pregnancy Test CVS Health One Step Pregnancy Test CareOne One Step Pregnancy Test Equate One Step Pregnancy Test Signature Care One Step Pregnancy Test Equaline One Step Pregnancy Test TopCare Health One Step Pregnancy Test Walgreens One Step Pregnancy Test Clearblue Early Digital Pregnancy Test Clearblue Triple Assurance Pregnancy Tests Clearblue Early & Digital Pregnancy Tests Clearblue Early Combo Pack Pregnancy Tests Clearblue Early Assurance Combo Pregnancy Tests Clearblue Fertility Monitor Test Sticks Clearblue Fertility Monitor with Touch Screen Clearblue Rapid Detection Pregnancy Test Clearblue Flip & Click Pregnancy Test Clearblue Rapid & Digital Pregnancy Tests Clearblue Triple Assurance Pregnancy Tests HEB 6 Days Sooner Pregnancy Test Walgreens 6 Days Sooner Pregnancy Test Meijer 6 Days Sooner Pregnancy Test DG Health 6 Days Sooner Pregnancy Test Amazon 6 Days Sooner Pregnancy Test Clearblue Bilingual Early Detection Pregnancy Test Clearblue Early & Digital Pregnancy Tests Clearblue Triple Assurance Pregnancy Tests UP & UP Early Visual & Early Digital Pregnancy Tests Clearblue Early Detection Pregnancy Test UP & UP 6 Days Sooner Pregnancy Test Clearblue Early Combo Pack Pregnancy Tests Clearblue Early Assurance Combo Pregnancy Tests CVS Health 6 Days Sooner Pregnancy Test Clearblue Trying for a Baby Ovulation Kit Clearblue & Natural Cycles° Birth Control Kit Starter Pack Clearblue Advanced Digital Ovulation Test Kit Clearblue Trying for a Baby Advanced Ovulation Kit Clearblue Digital Ovulation Test Clearblue Smart Ovulation Test Clearblue Advanced Digital Ovulation Test Clearblue Period Cycle Tracker TOPCARE HEALTH ONE STEP PREGNANCY TEST SIGNATURE CARE EARLY RESULT PREGNANCY TEST CVS HEALTH BILINGUAL EARLY RESULT PREGNANCY TEST EQUATE TRIPLE TEST PREGNANCY TEST KIT 7SELECT EARLY RESULT PREGNANCY TEST CVS HEALTH ADVANCED ONE STEP PREGNANCY TEST CAREONE EARLY RESULT PREGNANCY TEST ACCU-CLEAR PREGANCY TEST UP&UP ADVANCED EARLY RESULT PREGNANCY TEST SIGNATURE CARE ONE STEP PREGNANCY TEST MEIJER ADVANCED EARLY RESULT PREGNANCY TEST CVS HEALTH DIGITAL WIDE-TIP & ADVANCED ONE STEP PREGNANCY TESTS FIRST SIGNAL EARLY RESULT PREGNANCY TEST KROGER ADVANCED EARLY RESULT PREGNANCY TEST EQUALINE EARLY RESULT PREGNANCY TEST MEIJER CLEAR ANSWER ADVANCED ONE STEP PREGNANCY TEST WALGREENS TRIPLE TEST PREGNANCY TEST KIT KROGER ADVANCED ONE STEP +/- PREGNANCY TEST TOPCARE HEALTH EARLY RESULT PREGNANCY TEST DG Health One Step Pregnancy Test CVS HEALTH ONE STEP PREGNANCY TEST CVS TRIPLE TEST PREGNANCY TEST KIT Meijer Digital Wide-Tip & Early Result Pregnancy Tests EQUALINE ONE STEP PREGNANCY TEST Kroger Digital Wide-Tip & One Step Pregnancy Tests HEB ADVANCED ONE STEP PREGANCY TEST CVP Health One Step Pregnancy Test CAREONE ONE STEP PREGNANCY TEST Walgreens Digital & One Step Pregnancy Tests HEB ADVANCED EARLY RESULT PREGNANCY TEST WALGREENS EARLY RESULT PREGNANCY TEST WALGREENS ONE STEP PREGNANCY TEST HEB Digital Wide-Tip & Early Result Pregnancy Tests MEIJER CLEAR ANSWER ONE STEP PREGNANCY TEST AMAZON EARLY RESULT PREGNANCY TEST WALGREENS ADVANCED EARLY RESULT PREGNANCY TEST EQUATE ONE STEP PREGNANCY TEST CVS HEALTH DIGITAL WIDE-TIP & ADVANCED EARLY RESULT PREGNANCY TESTS MEIJER EARLY RESULT PREGNANCY TEST Rexall One Step Pregnancy Test CVS HEALTH EARLY RESULT PREGNANCY TEST WALGREENS ADVANCED ONE STEP PREGNANCY TEST Equate Advanced Early Result Pregnancy Test EXCHANGE SELECT ONE STEP PREGNANCY TEST FIRST SIGNAL ONE STEP PREGNANCY TEST Equate One Step Pregnancy Test H.E.B One-Step Cassette Pregnancy Test DG Health One Step Pregnancy Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2010-01-08
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2007-06-13
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2016-07-19
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2011-06-10
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2007-06-13
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2007-06-13
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2007-06-13
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2007-06-13
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2016-07-19
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2007-06-13
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2022-03-31
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2007-06-13
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2007-06-13
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2022-06-15
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2007-06-13
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2011-06-10
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2022-09-28
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2010-01-08
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2007-06-13
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2022-03-31

Official Correspondent

Cameron Houston

US Agent Details

YingYing Wang Email: yingying.wang@abbott.com Phone: (224) 5320210

Related Public Records

Same Entity

SPD SWISS PRECISION DIAGNOSTICS GMBH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K964108	Direct Access Diagnostics	FACT PLUS PREGNANCY TEST	1996-11-18
K945514	Princeton BioMeditech Corp.	LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG	1995-02-10
K150022	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream	2015-08-07
K043443	Guangzhou Wondfo Biotech Co., Ltd.	ONE STEP HCG URINE PREGNANCY TEST	2005-04-08
K173229	Guangzhou Wondfo Biotech Co., Ltd.	Preview Digital Pregnancy Test	2018-03-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01

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3013885851	CENTUM ELECTRONICS LIMITED	Bangalore Karnataka, IN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006635320. Last updated year: 2026. Please use registration number 3006635320 when referencing this establishment in official correspondence.