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 IDK193318
510k NumberK193318
Device Name:Distinct® Early Detection Pregnancy Test
ClassificationKit, Test, Pregnancy, Hcg, Over The Counter
Applicant Acon Laboratories Inc. 5850 Oberlin Drive #340 San Diego,  CA  92121
ContactQiyi Xie
CorrespondentQiyi Xie
Acon Laboratories Inc. 5850 Oberlin Drive #340 San Diego,  CA  92121
Product CodeLCX  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-02
Decision Date2020-08-20

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