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 a medical device manufactured by ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2020-08-20 under approval 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. It is manufactured by ACON Laboratories, Inc.. The 510(k) number is K193318.
When was Distinct® Early Detection Pregnancy Test approved by the FDA?
Distinct® Early Detection Pregnancy Test received FDA 510(k) clearance on 2020-08-20, under approval number K193318.
What company makes Distinct® Early Detection Pregnancy Test?
Distinct® Early Detection Pregnancy Test is manufactured by ACON Laboratories, Inc..
What is the FDA product code for Distinct® Early Detection Pregnancy Test?
The FDA product code for Distinct® Early Detection Pregnancy Test is LCX.
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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.