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FDA 510(k)

CARD GUARD MODEL CG-8000

K-Number: K926515 · 1994-03-30

ApplicantCard Guard Scientific Survival , Ltd.
Decision Date1994-03-30
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARD GUARD MODEL CG-8000 is the device name listed in this FDA 510(k) record. The listed applicant is Card Guard Scientific Survival , Ltd.. It received FDA 510(k) clearance on 1994-03-30 under 510(k) number K926515. 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 CARD GUARD MODEL CG-8000?

CARD GUARD MODEL CG-8000 is a medical device that received FDA 510(k) clearance on 1994-03-30. The listed applicant is Card Guard Scientific Survival , Ltd.. The 510(k) number is K926515.

When did CARD GUARD MODEL CG-8000 receive FDA 510(k) clearance?

CARD GUARD MODEL CG-8000 received FDA 510(k) clearance on 1994-03-30, under 510(k) number K926515.

Who is the listed applicant for CARD GUARD MODEL CG-8000?

The FDA 510(k) record lists Card Guard Scientific Survival , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARD GUARD MODEL CG-8000?

The FDA product code for CARD GUARD MODEL CG-8000 is DXH. This falls under the Hematology category.

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Other records listing Card Guard Scientific Survival , Ltd. 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.

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