Data / Medical devices / United Kingdom / SPD Development Company Limited
SPD Development Company Limited: FDA-registered device maker in Bedford, United Kingdom, 9 510(k) clearances
SPD Development Company Limited is registered with the FDA (registration 3007583565) in Bedford, United Kingdom. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated September 21, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007583565
- Address
- Priory Business Park Stannard Way, Bedford, United Kingdom, MK44 3UP
- Owner or operator
- SPD Development Company Limited (10028008)
- Roles
- Specification developer
- First device listed
- December 22, 2008
- Registered through
- 2026
- Brand names listed
- 7SELECT EARLY RESULT PREGNANCY TEST, Accu-Clear Pregnancy Test, CAREONE DIGITAL PREGNANCY TEST, CAREONE EARLY RESULT PREGNANCY TEST, CAREONE ONE STEP PREGNANCY TEST, CVS Early Ovulation Test Kit, CVS HEALTH BILINGUAL EARLY RESULT PREGNANCY TEST, CVS HEALTH DIGITAL & ONE STEP PREGNANCY TEST KIT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Specification developer | accessdata.fda.gov |
| Radioimmunoassay, Luteinizing Hormone | CEP | 1 | Specification developer | accessdata.fda.gov |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | 1 | Specification developer | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 21, 2022 | K213379 | Clearblue ® Early Pregnancy Test | LCX | Substantially Equivalent | Spd Swiss Precision Diagnostics GmbH | accessdata.fda.gov |
| March 10, 2022 | K210341 | One Step Pregnancy Test | LCX | Substantially Equivalent | Spd Swiss Precision Diagnostics GmbH | accessdata.fda.gov |
| August 13, 2021 | K200913 | Clearblue® Early Digital Pregnancy Test | LCX | Substantially Equivalent | Spd Swiss Precision Diagnostics GmbH | accessdata.fda.gov |
| May 12, 2011 | K110433 | CLEARBLUE EASY PREGNANCY TEST | LCX | Substantially Equivalent | SPD Development Company Limited | accessdata.fda.gov |
| May 25, 2006 | K060128 | CLEARBLUE EASY DIGITAL PREGNANCY TEST | LCX | Substantially Equivalent | Unipath , Ltd. | accessdata.fda.gov |
| September 10, 2004 | K042280 | FACT PLUS ONE-STEP PREGNANCY TEST KIT | LCX | Substantially Equivalent | Unipath , Ltd. | accessdata.fda.gov |
| May 25, 1999 | K991466 | EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) | CEP | Substantially Equivalent | Selfcare, Inc. | accessdata.fda.gov |
| October 28, 1998 | K981207 | CLEARPLAN EASY FERTILITY MONITOR | NGE | Substantially Equivalent | Unipath , Ltd. | accessdata.fda.gov |
| June 25, 1998 | K981271 | CLEARPLAN EASY OVULATION TEST | CEP | Substantially Equivalent | Unipath , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Radioimmunoassay, Luteinizing Hormone
- All makers of Test, Follicle Stimulating Hormone (Fsh), Over The Counter
Updated September 21, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.