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FDA 510(k)

UA-Cellular Complete

K-Number: K170091 · 2017-02-09

ApplicantStreck
Decision Date2017-02-09
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UA-Cellular Complete is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2017-02-09 under 510(k) number K170091. The device is classified under product code JJW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UA-Cellular Complete?

UA-Cellular Complete is a medical device that received FDA 510(k) clearance on 2017-02-09. The listed applicant is Streck. The 510(k) number is K170091.

When did UA-Cellular Complete receive FDA 510(k) clearance?

UA-Cellular Complete received FDA 510(k) clearance on 2017-02-09, under 510(k) number K170091.

Who is the listed applicant for UA-Cellular Complete?

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

What is the FDA product code for UA-Cellular Complete?

The FDA product code for UA-Cellular Complete is JJW.

Other records listing Streck 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.

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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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