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FDA 510(k)

DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132

K-Number: K011033 · 2001-06-07

ApplicantDade Behring, Inc.
Decision Date2001-06-07
Product CodeJIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 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 2001-06-07 under 510(k) number K011033. The device is classified under product code JIH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132?

DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 is a medical device that received FDA 510(k) clearance on 2001-06-07. The listed applicant is Dade Behring, Inc.. The 510(k) number is K011033.

When did DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 receive FDA 510(k) clearance?

DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 received FDA 510(k) clearance on 2001-06-07, under 510(k) number K011033.

Who is the listed applicant for DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132?

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 LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132?

The FDA product code for DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 is JIH.

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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.

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