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FDA 510(k)

COMINED STANDARD SOLUTION

K-Number: K130100 · 2013-04-18

Decision Date2013-04-18
Product CodeFKH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COMINED 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 2013-04-18 under 510(k) number K130100. 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 COMINED STANDARD SOLUTION?

COMINED STANDARD SOLUTION is a medical device that received FDA 510(k) clearance on 2013-04-18. The listed applicant is Mesa Laboratories, Inc.. The 510(k) number is K130100.

When did COMINED STANDARD SOLUTION receive FDA 510(k) clearance?

COMINED STANDARD SOLUTION received FDA 510(k) clearance on 2013-04-18, under 510(k) number K130100.

Who is the listed applicant for COMINED 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 COMINED STANDARD SOLUTION?

The FDA product code for COMINED STANDARD SOLUTION is FKH.

Related Clinical Trials

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.

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.

View all 7 devices →

Related Devices (Code: FKH)

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.

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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