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FDA 510(k)

MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

K-Number: K001118 · 2000-04-25

ApplicantDiaSorin, Inc.
Decision Date2000-04-25
Product CodeDFC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2000-04-25 under 510(k) number K001118. The device is classified under product code DFC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET?

MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET is a medical device that received FDA 510(k) clearance on 2000-04-25. The listed applicant is DiaSorin, Inc.. The 510(k) number is K001118.

When did MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET receive FDA 510(k) clearance?

MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET received FDA 510(k) clearance on 2000-04-25, under 510(k) number K001118.

Who is the listed applicant for MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET?

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

What is the FDA product code for MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET?

The FDA product code for MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET is DFC.

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Related Devices (Code: DFC)

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.

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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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