DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)
FDA 510(k) clearance K123677 · decided 2013-03-07
Clearance details
- K-number
- K123677
- Device name
- DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)
- Applicant
- Siemens Healthcare Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2012-11-30
- Decision date
- 2013-03-07
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- JIF
- Device class
- 1
- Regulation number
- 862.1065
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Ammonia II (K183517) | Roche Diagnostics Operations (Rdo) | 2019-02-08 |
| DIMENSION AMMONIA FLEX REAGENT CARTRIDGE (K123320) | Siemens Healthcare Diagnostics | 2013-02-15 |
| DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE (K062316) | Dade Behring, Inc. | 2006-09-06 |
| SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY (K051114) | Sentinel Ch. Srl | 2005-11-25 |
| AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 (K033921) | Diagnostic Chemicals , Ltd. | 2004-03-10 |
| RANDOX AMMONIA (K030873) | Randox Laboratories, Ltd. | 2003-05-12 |
| AMMONIA ASSAY FOR THE ADVIA 1650 (K023841) | Bayer Diagnostics Corp. | 2002-12-24 |
| AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K021151) | Bayer Diagnostics Corp. | 2002-07-13 |
| SYNCHRON SYSTEMS AMMONIA REAGENT (K003196) | Beckman Coulter, Inc. | 2000-12-22 |
| AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 (K001285) | Diagnostic Chemicals , Ltd. | 2000-06-02 |
| SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT (K984402) | Beckman Coulter, Inc. | 1999-01-29 |
| AMM (K981920) | Abbott Laboratories | 1998-07-22 |
Recalls involving this device
No recalls on record reference this clearance.
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