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FDA 510(k)

DIMENSION HAIC ASSAY, MODEL DF105

K-Number: K011852 · 2001-11-15

ApplicantDade Behring, Inc.
Decision Date2001-11-15
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DIMENSION HAIC ASSAY, MODEL DF105 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 2001-11-15 under 510(k) number K011852. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION HAIC ASSAY, MODEL DF105?

DIMENSION HAIC ASSAY, MODEL DF105 is a medical device that received FDA 510(k) clearance on 2001-11-15. The listed applicant is Dade Behring, Inc.. The 510(k) number is K011852.

When did DIMENSION HAIC ASSAY, MODEL DF105 receive FDA 510(k) clearance?

DIMENSION HAIC ASSAY, MODEL DF105 received FDA 510(k) clearance on 2001-11-15, under 510(k) number K011852.

Who is the listed applicant for DIMENSION HAIC ASSAY, MODEL DF105?

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 HAIC ASSAY, MODEL DF105?

The FDA product code for DIMENSION HAIC ASSAY, MODEL DF105 is LCP.

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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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