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FDA 510(k)

CoLink PCR Plating System

K-Number: K213698 · 2022-05-27

ApplicantIn2bones USA, LLC
Decision Date2022-05-27
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CoLink PCR Plating System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA, LLC. It received FDA 510(k) clearance on 2022-05-27 under 510(k) number K213698. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoLink PCR Plating System?

CoLink PCR Plating System is a medical device that received FDA 510(k) clearance on 2022-05-27. The listed applicant is In2bones USA, LLC. The 510(k) number is K213698.

When did CoLink PCR Plating System receive FDA 510(k) clearance?

CoLink PCR Plating System received FDA 510(k) clearance on 2022-05-27, under 510(k) number K213698.

Who is the listed applicant for CoLink PCR Plating System?

The FDA 510(k) record lists In2bones USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoLink PCR Plating System?

The FDA product code for CoLink PCR Plating System is HRS.

Other records listing In2bones USA, LLC as applicant

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Related Devices (Code: HRS)

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.

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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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