FDA 510(k)

DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A

K-Number: K032798 · 2003-10-30

Decision Date2003-10-30

Product CodeJHM

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A 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 2003-10-30 under 510(k) number K032798. 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 AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A?

DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A is a medical device that received FDA 510(k) clearance on 2003-10-30. The listed applicant is Dade Behring, Inc.. The 510(k) number is K032798.

When did DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A receive FDA 510(k) clearance?

DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A received FDA 510(k) clearance on 2003-10-30, under 510(k) number K032798.

Who is the listed applicant for DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A?

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 AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A?

The FDA product code for DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A is JHM.

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Other records listing Dade Behring, Inc. as applicant

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Related Devices (Code: JHM)

K120662PICCOLO HDL-CAPILLARY TEST SYSTEMAbaxis, Inc.K081300DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics K073072DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48BDade 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.