510(k) K062316
- Device
- DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE
- Applicant
- DADE BEHRING, INC.
- 510(k) number
- K062316
- Product code
- JIF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-09-06
- Date received
- 2006-08-09
- Regulation
- 862.1065
- Classification name
- Enzymatic Method, Ammonia
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LORRAINE H PIESTRAK
- Address
- Glasgow Business Community; Bldg. 500 Mail Box 514 P.O. Box 6101, Newark DE US 19714 19714
FDA Registration Numbers#
- 3002809144
- 9610529
- 8020316
- 3010825766
- 2517506
- 1827821
- 9681753
- 2050010
- 9610126
- 2050012
- 1181121
- 3005333358
- 3006198300
- 3003795116
- 3013660430
- 3004493545
- 2432235
- 2085064
Source Documents#
Other 510(k) Records For Product Code JIF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K183517 | Ammonia II | Roche Diagnostics Operations (Rdo) | 2019-02-08 |
| K123677 | DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) | Siemens Healthcare Diagnostics | 2013-03-07 |
| K123320 | DIMENSION AMMONIA FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics | 2013-02-15 |
| K051114 | SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY | Sentinel Ch. Srl | 2005-11-25 |
| K033921 | AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 | Diagnostic Chemicals , Ltd. | 2004-03-10 |
| K030873 | RANDOX AMMONIA | Randox Laboratories, Ltd. | 2003-05-12 |
| K023841 | AMMONIA ASSAY FOR THE ADVIA 1650 | Bayer Diagnostics Corp. | 2002-12-24 |
| K021151 | AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2002-07-13 |
| K003196 | SYNCHRON SYSTEMS AMMONIA REAGENT | Beckman Coulter, Inc. | 2000-12-22 |
| K001285 | AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 | Diagnostic Chemicals , Ltd. | 2000-06-02 |
| K984402 | SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT | Beckman Coulter, Inc. | 1999-01-29 |
| K981920 | AMM | Abbott Laboratories | 1998-07-22 |
| K981467 | AMM | Abbott Laboratories | 1998-06-22 |
| K974620 | AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) | Trace America, Inc. | 1998-01-02 |
| K964565 | PARAMAX AMMONIA AND AMMONIA BLANK REAGENT | Dade Intl., Inc. | 1996-11-22 |
Legacy Summary#
summary
FDA Review#
Decision Summary