Clearblue® Early Digital Pregnancy Test

Kit, Test, Pregnancy, Hcg, Over The Counter

SPD Swiss Precision Diagnostics GmbH

The following data is part of a premarket notification filed by Spd Swiss Precision Diagnostics Gmbh with the FDA for Clearblue® Early Digital Pregnancy Test.

Pre-market Notification Details

• Device ID: K200913
• 510k Number: K200913
• Device Name: Clearblue® Early Digital Pregnancy Test
• Classification: Kit, Test, Pregnancy, Hcg, Over The Counter
• Applicant: SPD Swiss Precision Diagnostics GmbH 47 Route De St Georges, Petit-Lancey Geneva, CH Ch-1213
• Contact: Joanne Scaife
• Correspondent: Kamila Przedmojska; SPD Development Company Priory Business Park Bedford, GB Mk44 3up
• Product Code: LCX
• CFR Regulation Number: 862.1155 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-04-06
• Decision Date: 2021-08-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10633472602259	K200913	000
10633472602266	K200913	000
10633472602341	K200913	000
10633472602334	K200913	000
10633472602327	K200913	000
10633472602310	K200913	000
10633472602303	K200913	000
10633472602488	K200913	000