FDA 510(k)

Ammonia II

K-Number: K183517 · 2019-02-08

ApplicantRoche Diagnostics Operations (Rdo)

Decision Date2019-02-08

Product CodeJIF

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Ammonia II is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2019-02-08 under 510(k) number K183517. The device is classified under product code JIF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ammonia II?

Ammonia II is a medical device that received FDA 510(k) clearance on 2019-02-08. The listed applicant is Roche Diagnostics Operations (Rdo). The 510(k) number is K183517.

When did Ammonia II receive FDA 510(k) clearance?

Ammonia II received FDA 510(k) clearance on 2019-02-08, under 510(k) number K183517.

Who is the listed applicant for Ammonia II?

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

What is the FDA product code for Ammonia II?

The FDA product code for Ammonia II is JIF.

Other records listing Roche Diagnostics Operations (Rdo) as applicant

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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.