Distinct® Early Detection Pregnancy Test

Kit, Test, Pregnancy, Hcg, Over The Counter

Acon Laboratories Inc.

The following data is part of a premarket notification filed by Acon Laboratories Inc. with the FDA for Distinct® Early Detection Pregnancy Test.

Pre-market Notification Details

• Device ID: K193318
• 510k Number: K193318
• Device Name: Distinct® Early Detection Pregnancy Test
• Classification: Kit, Test, Pregnancy, Hcg, Over The Counter
• Applicant: Acon Laboratories Inc. 5850 Oberlin Drive #340 San Diego, CA 92121
• Contact: Qiyi Xie
• Correspondent: Qiyi Xie; Acon Laboratories Inc. 5850 Oberlin Drive #340 San Diego, CA 92121
• Product Code: LCX
• CFR Regulation Number: 862.1155 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-12-02
• Decision Date: 2020-08-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20682607630558	K193318	000
10682607630544	K193318	000
10682607630308	K193318	000