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FDA 510(k)

COAG-CONTROL [N] KIT

K-Number: K922174 · 1992-10-26

ApplicantAmerican Bioproducts Co.
Decision Date1992-10-26
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAG-CONTROL [N] KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Bioproducts Co.. It received FDA 510(k) clearance on 1992-10-26 under 510(k) number K922174. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAG-CONTROL [N] KIT?

COAG-CONTROL [N] KIT is a medical device that received FDA 510(k) clearance on 1992-10-26. The listed applicant is American Bioproducts Co.. The 510(k) number is K922174.

When did COAG-CONTROL [N] KIT receive FDA 510(k) clearance?

COAG-CONTROL [N] KIT received FDA 510(k) clearance on 1992-10-26, under 510(k) number K922174.

Who is the listed applicant for COAG-CONTROL [N] KIT?

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

What is the FDA product code for COAG-CONTROL [N] KIT?

The FDA product code for COAG-CONTROL [N] KIT is GGN.

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Other records listing American Bioproducts Co. 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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