FDA 510(k)

DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)

K-Number: K123677 · 2013-03-07

Decision Date2013-03-07

Product CodeJIF

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) 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 2013-03-07 under 510(k) number K123677. 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 VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)?

DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) is a medical device that received FDA 510(k) clearance on 2013-03-07. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K123677.

When did DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) receive FDA 510(k) clearance?

DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) received FDA 510(k) clearance on 2013-03-07, under 510(k) number K123677.

Who is the listed applicant for DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)?

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 VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)?

The FDA product code for DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) is JIF.

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Related Devices (Code: JIF)

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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.