TDS Standard Solution
K-Number: K191496 · 2019-08-05
ApplicantMesa Laboratories, Inc.
Decision Date2019-08-05
Product CodeFKH
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
TDS Standard Solution is a medical device manufactured by Mesa Laboratories, Inc.. It received FDA 510(k) clearance on 2019-08-05 under approval number K191496. The device is classified under product code FKH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TDS Standard Solution?
TDS Standard Solution is a medical device that received FDA 510(k) clearance on 2019-08-05. It is manufactured by Mesa Laboratories, Inc.. The 510(k) number is K191496.
When was TDS Standard Solution approved by the FDA?
TDS Standard Solution received FDA 510(k) clearance on 2019-08-05, under approval number K191496.
What company makes TDS Standard Solution?
TDS Standard Solution is manufactured by Mesa Laboratories, Inc..
What is the FDA product code for TDS Standard Solution?
The FDA product code for TDS Standard Solution is FKH.
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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.