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FDA 510(k)

FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST

K-Number: K013263 · 2002-07-29

ApplicantFred Hutchinson Cancer Research Center
Decision Date2002-07-29
Product CodeLKP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Fred Hutchinson Cancer Research Center. It received FDA 510(k) clearance on 2002-07-29 under 510(k) number K013263. The device is classified under product code LKP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST?

FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 2002-07-29. The listed applicant is Fred Hutchinson Cancer Research Center. The 510(k) number is K013263.

When did FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST receive FDA 510(k) clearance?

FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST received FDA 510(k) clearance on 2002-07-29, under 510(k) number K013263.

Who is the listed applicant for FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST?

The FDA 510(k) record lists Fred Hutchinson Cancer Research Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST?

The FDA product code for FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST is LKP.

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Related Devices (Code: LKP)

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

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