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FDA 510(k)

DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B

K-Number: K073072 · 2008-02-21

ApplicantDade Behring, Inc.
Decision Date2008-02-21
Product CodeJHM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B 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 2008-02-21 under 510(k) number K073072. The device is classified under product code JHM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B?

DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B is a medical device that received FDA 510(k) clearance on 2008-02-21. The listed applicant is Dade Behring, Inc.. The 510(k) number is K073072.

When did DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B receive FDA 510(k) clearance?

DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B received FDA 510(k) clearance on 2008-02-21, under 510(k) number K073072.

Who is the listed applicant for DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B?

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 AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B?

The FDA product code for DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B is JHM.

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Related Devices (Code: JHM)

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.

K120662PICCOLO HDL-CAPILLARY TEST SYSTEMAbaxis, Inc.K081300DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGESiemens Healthcare DiagnosticsK032798DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48ADade Behring, Inc.K022519LDL CHOLESTEROL (AUTOMATED)Jas Diagnostics, Inc.K983849DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGEDade Behring, Inc.K902935ROCHE COBAS READY HDL CHOLESTEROL REAGENTRoche Diagnostic Systems, Inc.

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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