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FDA 510(k)

Jac-Cell Medic testers

K-Number: K170105 · 2017-02-28

Decision Date2017-02-28
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Jac-Cell Medic testers is the device name listed in this FDA 510(k) record. The listed applicant is Jac-Cell Medic. It received FDA 510(k) clearance on 2017-02-28 under 510(k) number K170105. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Jac-Cell Medic testers?

Jac-Cell Medic testers is a medical device that received FDA 510(k) clearance on 2017-02-28. The listed applicant is Jac-Cell Medic. The 510(k) number is K170105.

When did Jac-Cell Medic testers receive FDA 510(k) clearance?

Jac-Cell Medic testers received FDA 510(k) clearance on 2017-02-28, under 510(k) number K170105.

Who is the listed applicant for Jac-Cell Medic testers?

The FDA 510(k) record lists Jac-Cell Medic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Jac-Cell Medic testers?

The FDA product code for Jac-Cell Medic testers is GEI.

Related Devices (Code: GEI)

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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