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FDA 510(k)

DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605

K-Number: K100344 · 2011-04-18

ApplicantSiemens Healthcare Diagnostics
Decision Date2011-04-18
Product CodeMOI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 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 2011-04-18 under 510(k) number K100344. The device is classified under product code MOI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605?

DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 is a medical device that received FDA 510(k) clearance on 2011-04-18. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K100344.

When did DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 receive FDA 510(k) clearance?

DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 received FDA 510(k) clearance on 2011-04-18, under 510(k) number K100344.

Who is the listed applicant for DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605?

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 LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605?

The FDA product code for DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 is MOI.

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Related Devices (Code: MOI)

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K240403Access BR MonitorBeckman Coulter, Inc.K233946IMMULITE® 2000 BR-MASiemens Healthcare Diagnostics Products, Ltd.K192524Lumipulse G CA15-3Fujirebio Diagnostics,Inc.K193489ADVIA Centaur BRSiemens Healthcare Diagnostics, Inc.K192777ADVIA Centaur CA 15-3 assaySiemens Healthcare Diagnostics, Inc.K181492Elecsys CA 15-3 IIRoche Diagnostics

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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