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FDA 510(k)

ACTICLOT, MODEL 824

K-Number: K052124 · 2005-10-17

ApplicantAmerican Diagnostica, Inc.
Decision Date2005-10-17
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACTICLOT, MODEL 824 is the device name listed in this FDA 510(k) record. The listed applicant is American Diagnostica, Inc.. It received FDA 510(k) clearance on 2005-10-17 under 510(k) number K052124. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTICLOT, MODEL 824?

ACTICLOT, MODEL 824 is a medical device that received FDA 510(k) clearance on 2005-10-17. The listed applicant is American Diagnostica, Inc.. The 510(k) number is K052124.

When did ACTICLOT, MODEL 824 receive FDA 510(k) clearance?

ACTICLOT, MODEL 824 received FDA 510(k) clearance on 2005-10-17, under 510(k) number K052124.

Who is the listed applicant for ACTICLOT, MODEL 824?

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

What is the FDA product code for ACTICLOT, MODEL 824?

The FDA product code for ACTICLOT, MODEL 824 is GJS.

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Other records listing American Diagnostica, Inc. 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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