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FDA 510(k)

CARD GUARD, MODEL CG-7100

K-Number: K964836 · 1997-07-28

ApplicantCard Guard Scientific Survival , Ltd.
Decision Date1997-07-28
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARD GUARD, MODEL CG-7100 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 1997-07-28 under 510(k) number K964836. 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-7100?

CARD GUARD, MODEL CG-7100 is a medical device that received FDA 510(k) clearance on 1997-07-28. The listed applicant is Card Guard Scientific Survival , Ltd.. The 510(k) number is K964836.

When did CARD GUARD, MODEL CG-7100 receive FDA 510(k) clearance?

CARD GUARD, MODEL CG-7100 received FDA 510(k) clearance on 1997-07-28, under 510(k) number K964836.

Who is the listed applicant for CARD GUARD, MODEL CG-7100?

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-7100?

The FDA product code for CARD GUARD, MODEL CG-7100 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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