Atlas FDA

DIMENSION AMMONIA FLEX REAGENT CARTRIDGE

FDA 510(k) clearance K123320 · decided 2013-02-15

Clearance details

K-number
K123320
Device name
DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2012-10-26
Decision date
2013-02-15
Days to decision
112 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.

RecordFirmDate
Ammonia II (K183517)Roche Diagnostics Operations (Rdo)2019-02-08
DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) (K123677)Siemens Healthcare Diagnostics2013-03-07
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE (K062316)Dade Behring, Inc.2006-09-06
SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY (K051114)Sentinel Ch. Srl2005-11-25
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 Laboratories1998-07-22

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Atellica IM Hepatitis B core IgM (aHBcM) (P030040/S024)Siemens Healthcare Diagnostics2025-10-17
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ADVIA Centaur® PSA Immunoassay; Atellica IM Prostate-Specific Antigen (PSA) (P950021/S030)Siemens Healthcare Diagnostics2025-07-16
ADVIA Centaur® Complexed PSA (cPSA) Immunoassay; Atellica IM Complexed Prostate-Specific Antigen (cPSA) (P990055/S029)Siemens Healthcare Diagnostics2025-07-16
Dimension TPSA Flex reagent cartridge (P000021/S047)Siemens Healthcare Diagnostics2025-05-22
Dimension FPSA Flex reagent cartridge (P020027/S042)Siemens Healthcare Diagnostics2025-05-22
Dimension FPSA Flex reagent cartridge (P020027/S041)Siemens Healthcare Diagnostics2025-02-24
Dimension TPSA Flex reagent cartridge (P000021/S046)Siemens Healthcare Diagnostics2025-02-24