Ammonia II— 510(k) K183517
Substantially EquivalentRoche Diagnostics Operations (Rdo)
FDA 510(k) clearance K183517 for Ammonia II, Substantially Equivalent on 2019-02-08. Applicant: Roche Diagnostics Operations (Rdo). Device class: 1.
Clearance details
- Applicant
- Roche Diagnostics Operations (Rdo)
- Product code
- Code JIF
- Device class
- Class 1
- Regulation
- 21 CFR 862.1065
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
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- K051114 — SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY
- K033921 — AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
More clearances from Roche Diagnostics Operations (Rdo)
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