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FDA 510(k)

PURPLE/BLACK HEPARIN ASSAY CONTROL

K-Number: K042206 · 2004-10-18

ApplicantMedtronic Vascular
Decision Date2004-10-18
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PURPLE/BLACK HEPARIN ASSAY CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2004-10-18 under 510(k) number K042206. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PURPLE/BLACK HEPARIN ASSAY CONTROL?

PURPLE/BLACK HEPARIN ASSAY CONTROL is a medical device that received FDA 510(k) clearance on 2004-10-18. The listed applicant is Medtronic Vascular. The 510(k) number is K042206.

When did PURPLE/BLACK HEPARIN ASSAY CONTROL receive FDA 510(k) clearance?

PURPLE/BLACK HEPARIN ASSAY CONTROL received FDA 510(k) clearance on 2004-10-18, under 510(k) number K042206.

Who is the listed applicant for PURPLE/BLACK HEPARIN ASSAY CONTROL?

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

What is the FDA product code for PURPLE/BLACK HEPARIN ASSAY CONTROL?

The FDA product code for PURPLE/BLACK HEPARIN ASSAY CONTROL is GGN.

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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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