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FDA 510(k)

KING OF HEARTS

K-Number: K880626 · 1988-04-11

ApplicantInstromedix, Inc.
Decision Date1988-04-11
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KING OF HEARTS is the device name listed in this FDA 510(k) record. The listed applicant is Instromedix, Inc.. It received FDA 510(k) clearance on 1988-04-11 under 510(k) number K880626. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KING OF HEARTS?

KING OF HEARTS is a medical device that received FDA 510(k) clearance on 1988-04-11. The listed applicant is Instromedix, Inc.. The 510(k) number is K880626.

When did KING OF HEARTS receive FDA 510(k) clearance?

KING OF HEARTS received FDA 510(k) clearance on 1988-04-11, under 510(k) number K880626.

Who is the listed applicant for KING OF HEARTS?

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

What is the FDA product code for KING OF HEARTS?

The FDA product code for KING OF HEARTS is DXH. This falls under the Hematology category.

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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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