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FDA 510(k)

DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON

K-Number: K072965 · 2007-12-21

ApplicantDade Behring, Inc.
Decision Date2007-12-21
Product CodeDBA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2007-12-21 under 510(k) number K072965. The device is classified under product code DBA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON?

DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON is a medical device that received FDA 510(k) clearance on 2007-12-21. The listed applicant is Dade Behring, Inc.. The 510(k) number is K072965.

When did DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON receive FDA 510(k) clearance?

DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON received FDA 510(k) clearance on 2007-12-21, under 510(k) number K072965.

Who is the listed applicant for DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON?

The FDA 510(k) record lists Dade Behring, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON?

The FDA product code for DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON is DBA.

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Related Devices (Code: DBA)

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.

K122304HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUSThe Binding Site Group , Ltd.K011780K-ASSAY C1-INAKamiya Biomedical Co.K003747C1-INHIBITOR MICROTITER ASSAY DEVICEBaxter Healthcare CorpK965024N-ASSAY TIA C1-INACTIVATOR TEST KITCrestat Diagnostics, Inc.K960257N ANTISERUM TO C1 INHIBITORBehring Diagnostics, Inc.K951967HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KITKent Laboratories, Inc.

Official Source

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

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