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
10050428166786	K213379	000
00633472000683	K213379	000
00633472000126	K213379	000
00633472000690	K213379	000