FDA 510(k)

ARCOLITH 4000

K-Number: K791165 · 1979-07-10

Decision Date1979-07-10

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ARCOLITH 4000 is the device name listed in this FDA 510(k) record. The listed applicant is Arco Medical Products Co.. It received FDA 510(k) clearance on 1979-07-10 under 510(k) number K791165. 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 ARCOLITH 4000?

ARCOLITH 4000 is a medical device that received FDA 510(k) clearance on 1979-07-10. The listed applicant is Arco Medical Products Co.. The 510(k) number is K791165.

When did ARCOLITH 4000 receive FDA 510(k) clearance?

ARCOLITH 4000 received FDA 510(k) clearance on 1979-07-10, under 510(k) number K791165.

Who is the listed applicant for ARCOLITH 4000?

The FDA 510(k) record lists Arco Medical Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARCOLITH 4000?

The FDA product code for ARCOLITH 4000 is DXY. This falls under the Clinical Chemistry category.

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Other records listing Arco Medical Products Co. as applicant

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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.