Clearblue ® Early 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 Pregnancy Test.

Pre-market Notification Details

• Device ID: K213379
• 510k Number: K213379
• Device Name: Clearblue ® Early Pregnancy Test
• Classification: Kit, Test, Pregnancy, Hcg, Over The Counter
• Applicant: SPD Swiss Precision Diagnostics GmbH 47 Route De Saint Georges, Petit-Lancy Geneva, CH CH-1213
• Contact: Joanne Scaife
• Correspondent: Kamila Przedmojska; SPD Development Company Limited Priory Business Park, Stannard Way 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: 2021-10-13
• Decision Date: 2022-09-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10633472602297	K213379	000
10633472602280	K213379	000
10633472602273	K213379	000
10633472602365	K213379	000