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FDA 510(k)

GLP systems Track

K-Number: K213486 · 2022-03-10

ApplicantAbbott Laboratories
Decision Date2022-03-10
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLP systems Track is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2022-03-10 under 510(k) number K213486. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLP systems Track?

GLP systems Track is a medical device that received FDA 510(k) clearance on 2022-03-10. The listed applicant is Abbott Laboratories. The 510(k) number is K213486.

When did GLP systems Track receive FDA 510(k) clearance?

GLP systems Track received FDA 510(k) clearance on 2022-03-10, under 510(k) number K213486.

Who is the listed applicant for GLP systems Track?

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

What is the FDA product code for GLP systems Track?

The FDA product code for GLP systems Track is JGS.

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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.

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