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FDA 510(k)

LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40

K-Number: K041927 · 2004-11-23

ApplicantDiagnostic Chemicals , Ltd.
Decision Date2004-11-23
Product CodeMRR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 2004-11-23 under 510(k) number K041927. The device is classified under product code MRR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40?

LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 is a medical device that received FDA 510(k) clearance on 2004-11-23. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K041927.

When did LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 receive FDA 510(k) clearance?

LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 received FDA 510(k) clearance on 2004-11-23, under 510(k) number K041927.

Who is the listed applicant for LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40?

The FDA 510(k) record lists Diagnostic Chemicals , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40?

The FDA product code for LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 is MRR.

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Related Devices (Code: MRR)

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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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