Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007583565

FEI Number

3007583565

Entity Name

SPD DEVELOPMENT COMPANY LIMITED

City/State/Country

Bedford, GB

Establishment Address

Priory Business Park, Stannard Way, Bedford MK44 3UP, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

SPD Development Company Limited (Owner Number: 10028008)

Owner / Operator Contact Address

Clearblue Innovation Centre, Stannard Way, Bedford, GB-BDF MK44 3UP, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K981207

PMA Number

N/A

All Registered Proprietary Names

WALGREENS ADVANCED EARLY RESULT PREGNANCY TEST TOPCARE HEALTH EARLY RESULT PREGNANCY TEST CVS HEALTH EARLY RESULT PREGNANCY TEST MEIJER EARLY RESULT PREGNANCY TEST TOPCARE HEALTH ONE STEP PREGNANCY TEST HEB ADVANCED ONE STEP PREGANCY TEST WALGREENS ONE STEP PREGNANCY TEST SIGNATURE CARE EARLY RESULT PREGNANCY TEST CVS HEALTH BILINGUAL EARLY RESULT PREGNANCY TEST EQUATE TRIPLE TEST PREGNANCY TEST KIT First Signal Early Result Pregnancy Test CVS Health Advanced One Step Pregnancy Test SIGNATURE CARE ONE STEP PREGNANCY TEST EXCHANGE SELECT ONE STEP PREGNANCY TEST MEIJER ADVANCED EARLY RESULT PREGNANCY TEST CAREONE EARLY RESULT PREGNANCY TEST CVS TRIPLE TEST PREGNANCY TEST KIT CVS HEALTH DIGITAL WIDE-TIP PREGNANCY TEST Accu-Clear Pregnancy Test UP&UP ADVANCED EARLY RESULT PREGNANCY TEST MEIJER CLEAR ANSWER ADVANCED ONE STEP PREGNANCY TEST KROGER ADVANCED EARLY RESULT PREGNANCY TEST KROGER ADVANCED ONE STEP +/- PREGNANCY TEST WALGREENS TRIPLE STEP PREGNANCY TEST KIT EQUATE ONE STEP PREGNANCY TEST 7SELECT EARLY RESULT PREGNANCY TEST CVS HEALTH ONE STEP PREGNANCY TEST EQUALINE EARLY RESULT PREGANCY TEST CAREONE ONE STEP PREGNANCY TEST HEB ADVANCED EARLY RESULT PREGNANCY TEST EQUALINE ONE STEP PREGNANCY TEST MEIJER CLEAR ANSWER ONE STEP PREGNANCY TEST CVS Health Daily Ovulation Test Strips Clearblue Early Digital Pregnancy Test Clearblue Triple Assurance Pregnancy Tests Clearblue Triple Assurance Pregnancy Tests Clearblue Rapid Detection Pregnancy Test Clearblue Flip & Click Pregnancy Test Clearblue Rapid & Digital Pregnancy Tests Equate Early Ovulation Test Clearblue Easy Ovulation Kit CVS Early Ovulation Test Kit KROGER EARLY OVULATON TEST UP&UP EARLY OVULATION TEST TOPCARE HEALTH EARLY OVULATION TEST HEB EARLY OVULATION KIT TEST MEIJER CLEAR ANSWER EARLY OVULATION TEST Clearblue Early Detection Pregnancy Test Clearblue Triple Assurance Pregnancy Tests Clearblue Fertility Monitor Test Sticks Clearblue Fertility Monitor with Touch Screen

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2008-12-22
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2013-12-17
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2022-06-15
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2023-05-26
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2011-06-10
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2008-12-22
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	2008-12-22

Official Correspondent

Cameron Houston

US Agent Details

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

Related Public Records

Same Entity

SPD Development Company Limited

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-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01
Z-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01

Similar Registrations

Registration Number	Establishment Name	Location
1051594	CORDICA MEDICAL, INC. (Formally TEAM Technologies, Inc.)	MORRISTOWN, TN, US
3012725363	EASY HEALTHCARE CORPORATION	Darien, IL, US
1649661	GERMAINE LABORATORIES, INC.	SAN ANTONIO, TX, US
3003741676	ANDON HEALTH CO., LTD	TIANJIN, CN
3016609999	GENABIO DIAGNOSTICS INC	Bedford, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007583565. Last updated year: 2026. Please use registration number 3007583565 when referencing this establishment in official correspondence.