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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Mesa Laboratories, Inc.. It received FDA 510(k) clearance on 2019-08-05 under 510(k) 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. The listed applicant is Mesa Laboratories, Inc.. The 510(k) number is K191496.

When did TDS Standard Solution receive FDA 510(k) clearance?

TDS Standard Solution received FDA 510(k) clearance on 2019-08-05, under 510(k) number K191496.

Who is the listed applicant for TDS Standard Solution?

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

What is the FDA product code for TDS Standard Solution?

The FDA product code for TDS Standard Solution is FKH.

Other records listing Mesa 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.

K201765SmartHDM-510 System

Official Source

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

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