Ammonia II
by Roche Diagnostics Operations (Rdo)
510(k) K183517
Ammonia II is a Class I device made by Roche Diagnostics Operations (Rdo), cleared under FDA 510(k) K183517 on 8 Feb 2019, active as of 12 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK183517 | Date8 Feb 2019 | StatusActive |
Official records
- FDA 510(k) database K183517
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JIF
- Device class
- Class I
- Regulation
- 21 CFR Part 862.1065
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K183517
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Ammonia II 07229593190 | 07229593190 / 07229593190 | 04015630936526 | — | On the market |
| Ammonia II 07236450190 | 07236450190 / 07236450190 | 04015630936533 | — | On the market |
| Ammonia II 08058024190 | 08058024190 / 08058024190 | 07613336121429 | — | On the market |
Similar devices
Other devices filed under FDA product code JIF (Enzymatic Method, Ammonia).
- DIMENSION AMMONIA FLEX REAGENT CARTRIDGE by Siemens Healthcare Diagnostics
- AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 by Diagnostic Chemicals, Ltd.
- EASY-TEST AMMONIA (AMON) ITEM NO. 16695 by Em Diagnostic Systems, Inc.
- DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE by Dade Behring, Inc.
- ACA AMMONIA ANALYTICAL TEST PACK by E.I. Dupont DE Nemours & Co., Inc.
- SYNCHRON SYSTEMS AMMONIA REAGENT by Beckman Coulter, Inc.
- BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR by Beckman Instruments, Inc.
- AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95 by Em Diagnostic Systems, Inc.
- AMMONIA REAGENT by Gilford Diagnostics
- AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) by Trace America, Inc.