FDA 510(k)

MULTICOR GAMMA 402 SERIES PACER

K-Number: K851419 · 1985-06-11

Decision Date1985-06-11

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MULTICOR GAMMA 402 SERIES PACER is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1985-06-11 under 510(k) number K851419. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTICOR GAMMA 402 SERIES PACER?

MULTICOR GAMMA 402 SERIES PACER is a medical device that received FDA 510(k) clearance on 1985-06-11. The listed applicant is Cordis Corp.. The 510(k) number is K851419.

When did MULTICOR GAMMA 402 SERIES PACER receive FDA 510(k) clearance?

MULTICOR GAMMA 402 SERIES PACER received FDA 510(k) clearance on 1985-06-11, under 510(k) number K851419.

Who is the listed applicant for MULTICOR GAMMA 402 SERIES PACER?

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

What is the FDA product code for MULTICOR GAMMA 402 SERIES PACER?

The FDA product code for MULTICOR GAMMA 402 SERIES PACER is DXY. This falls under the Clinical Chemistry category.

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Related Devices (Code: DXY)

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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.