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FDA 510(k)

DIMENSION AMMONIA FLEX REAGENT CARTRIDGE

K-Number: K123320 · 2013-02-15

ApplicantSiemens Healthcare Diagnostics
Decision Date2013-02-15
Product CodeJIF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIMENSION AMMONIA FLEX REAGENT CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2013-02-15 under 510(k) number K123320. The device is classified under product code JIF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION AMMONIA FLEX REAGENT CARTRIDGE?

DIMENSION AMMONIA FLEX REAGENT CARTRIDGE is a medical device that received FDA 510(k) clearance on 2013-02-15. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K123320.

When did DIMENSION AMMONIA FLEX REAGENT CARTRIDGE receive FDA 510(k) clearance?

DIMENSION AMMONIA FLEX REAGENT CARTRIDGE received FDA 510(k) clearance on 2013-02-15, under 510(k) number K123320.

Who is the listed applicant for DIMENSION AMMONIA FLEX REAGENT CARTRIDGE?

The FDA 510(k) record lists Siemens Healthcare Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIMENSION AMMONIA FLEX REAGENT CARTRIDGE?

The FDA product code for DIMENSION AMMONIA FLEX REAGENT CARTRIDGE is JIF.

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Related Devices (Code: JIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183517Ammonia IIRoche Diagnostics Operations (Rdo)K123677DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)Siemens Healthcare DiagnosticsK062316DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGEDade Behring, Inc.K051114SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAYSentinel Ch. SrlK033921AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10Diagnostic Chemicals , Ltd.K030873RANDOX AMMONIARandox Laboratories, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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