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