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 a medical device manufactured by Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2019-02-08 under approval 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. It is manufactured by Roche Diagnostics Operations (Rdo). The 510(k) number is K183517.
When was Ammonia II approved by the FDA?
Ammonia II received FDA 510(k) clearance on 2019-02-08, under approval number K183517.
What company makes Ammonia II?
Ammonia II is manufactured by Roche Diagnostics Operations (Rdo).
What is the FDA product code for Ammonia II?
The FDA product code for Ammonia II is JIF.
Other Devices by Roche Diagnostics Operations (Rdo)
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.