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FDA 510(k)

ACTICLOT C KIT

K-Number: K884941 · 1989-03-13

ApplicantAmerican Diagnostic Corp.
Decision Date1989-03-13
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACTICLOT C KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Diagnostic Corp.. It received FDA 510(k) clearance on 1989-03-13 under 510(k) number K884941. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTICLOT C KIT?

ACTICLOT C KIT is a medical device that received FDA 510(k) clearance on 1989-03-13. The listed applicant is American Diagnostic Corp.. The 510(k) number is K884941.

When did ACTICLOT C KIT receive FDA 510(k) clearance?

ACTICLOT C KIT received FDA 510(k) clearance on 1989-03-13, under 510(k) number K884941.

Who is the listed applicant for ACTICLOT C KIT?

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

What is the FDA product code for ACTICLOT C KIT?

The FDA product code for ACTICLOT C KIT is GGP.

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Other records listing American Diagnostic Corp. 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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