QwikCheck Chemical Indicators
K-Number: K192445 · 2020-04-02
ApplicantSerim Research Corporation
Decision Date2020-04-02
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
QwikCheck Chemical Indicators is a medical device manufactured by Serim Research Corporation. It received FDA 510(k) clearance on 2020-04-02 under approval number K192445. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the QwikCheck Chemical Indicators?
QwikCheck Chemical Indicators is a medical device that received FDA 510(k) clearance on 2020-04-02. It is manufactured by Serim Research Corporation. The 510(k) number is K192445.
When was QwikCheck Chemical Indicators approved by the FDA?
QwikCheck Chemical Indicators received FDA 510(k) clearance on 2020-04-02, under approval number K192445.
What company makes QwikCheck Chemical Indicators?
QwikCheck Chemical Indicators is manufactured by Serim Research Corporation.
What is the FDA product code for QwikCheck Chemical Indicators?
The FDA product code for QwikCheck Chemical Indicators is JOJ.
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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.