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

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20682607630558 K193318 000
10682607630544 K193318 000
10682607630308 K193318 000

Trademark Results [Distinct]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DISTINCT
DISTINCT
98527753 not registered Live/Pending
Distinct Technologies, Inc.
2024-04-30
DISTINCT
DISTINCT
98527739 not registered Live/Pending
Distinct Technologies, Inc.
2024-04-30
DISTINCT
DISTINCT
98395887 not registered Live/Pending
Distinct Tax Consulting Group, LLC
2024-02-07
DISTINCT
DISTINCT
97786007 not registered Live/Pending
Medica Health Plans
2023-02-08
DISTINCT
DISTINCT
97771331 not registered Live/Pending
Distinct Technologies, Inc.
2023-01-27
DISTINCT
DISTINCT
97771321 not registered Live/Pending
Distinct Technologies, Inc.
2023-01-27
DISTINCT
DISTINCT
90001473 not registered Live/Pending
First National of Nebraska, Inc.
2020-06-15
DISTINCT
DISTINCT
88405533 not registered Live/Pending
Medica Health Plans
2019-04-27
DISTINCT
DISTINCT
88210139 not registered Live/Pending
Multy Home LP
2018-11-29
DISTINCT
DISTINCT
88150118 5757232 Live/Registered
Exeter, Trudon
2018-10-10
DISTINCT
DISTINCT
88000860 5858473 Live/Registered
Aquino Rojoeyl
2018-06-14
DISTINCT
DISTINCT
87856395 not registered Live/Pending
Andy Lu
2018-03-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.