Data / Medical devices / Switzerland / SPD Swiss Precision Diagnostics GMBH
SPD Swiss Precision Diagnostics GMBH: FDA-registered device maker in PETIT LANCY, GENEVA Geneve, Switzerland, 9 510(k) clearances
SPD Swiss Precision Diagnostics GMBH is registered with the FDA (registration 3006635320) in PETIT LANCY, GENEVA Geneve, Switzerland. It lists 3 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 3, 2026.
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- FDA registration number
- 3006635320
- Address
- C O Procter & Gamble 47 Route De Saint Georges, PETIT LANCY, GENEVA Geneve, Switzerland, 1213 CH
- Owner or operator
- SPD SWISS PRECISION DIAGNOSTICS GMBH (9102922)
- Roles
- Exporter to the US, Specification developer
- First device listed
- June 13, 2007
- Registered through
- 2026
- Brand names listed
- 7SELECT EARLY RESULT PREGNANCY TEST, ACCU-CLEAR PREGANCY TEST, AMAZON EARLY RESULT PREGNANCY TEST, Amazon 6 Days Sooner Pregnancy Test, Amazon Digital Pregnancy Test, Amazon Digital Wide-Tip Pregnancy Test, CAREONE EARLY RESULT PREGNANCY TEST, CAREONE ONE STEP PREGNANCY TEST and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Radioimmunoassay, Luteinizing Hormone | CEP | 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 |
| August 7, 2001 | K012215 | QUIK-CHECK HOME PREGNANCY TEST | LCX | Substantially Equivalent | ACON Laboratories, 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 Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
- All makers of Radioimmunoassay, Luteinizing Hormone
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.