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FDA 510(k)

Distinct® Early Detection Pregnancy Test

K-Number: K193318 · 2020-08-20

ApplicantACON Laboratories, Inc.
Decision Date2020-08-20
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Distinct® Early Detection Pregnancy Test is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2020-08-20 under 510(k) number K193318. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Distinct® Early Detection Pregnancy Test?

Distinct® Early Detection Pregnancy Test is a medical device that received FDA 510(k) clearance on 2020-08-20. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K193318.

When did Distinct® Early Detection Pregnancy Test receive FDA 510(k) clearance?

Distinct® Early Detection Pregnancy Test received FDA 510(k) clearance on 2020-08-20, under 510(k) number K193318.

Who is the listed applicant for Distinct® Early Detection Pregnancy Test?

The FDA 510(k) record lists ACON Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Distinct® Early Detection Pregnancy Test?

The FDA product code for Distinct® Early Detection Pregnancy Test is LCX.

Other records listing ACON Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LCX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy TestGuangzhou Decheng Biotechnology Co., Ltd.K251053Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd.K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLCK242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test MidstreamNanjing Synthgene Medical Technology Co., Ltd.K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamAssure Tech., LLCK241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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