FDA 510(k)

MULTICOR (GAMMA) MODEL 336 & MODEL 337

K-Number: K801106 · 1980-07-08

Decision Date1980-07-08

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MULTICOR (GAMMA) MODEL 336 & MODEL 337 is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1980-07-08 under 510(k) number K801106. 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) MODEL 336 & MODEL 337?

MULTICOR (GAMMA) MODEL 336 & MODEL 337 is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is Cordis Corp.. The 510(k) number is K801106.

When did MULTICOR (GAMMA) MODEL 336 & MODEL 337 receive FDA 510(k) clearance?

MULTICOR (GAMMA) MODEL 336 & MODEL 337 received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801106.

Who is the listed applicant for MULTICOR (GAMMA) MODEL 336 & MODEL 337?

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) MODEL 336 & MODEL 337?

The FDA product code for MULTICOR (GAMMA) MODEL 336 & MODEL 337 is DXY. This falls under the Clinical Chemistry category.

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Related Devices (Code: DXY)

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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.