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FDA 510(k)

COAG-A-MATE X2

K-Number: K813564 · 1982-01-28

Decision Date1982-01-28
Product CodeGKP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAG-A-MATE X2 is the device name listed in this FDA 510(k) record. The listed applicant is General Diagnostics. It received FDA 510(k) clearance on 1982-01-28 under 510(k) number K813564. The device is classified under product code GKP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAG-A-MATE X2?

COAG-A-MATE X2 is a medical device that received FDA 510(k) clearance on 1982-01-28. The listed applicant is General Diagnostics. The 510(k) number is K813564.

When did COAG-A-MATE X2 receive FDA 510(k) clearance?

COAG-A-MATE X2 received FDA 510(k) clearance on 1982-01-28, under 510(k) number K813564.

Who is the listed applicant for COAG-A-MATE X2?

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

What is the FDA product code for COAG-A-MATE X2?

The FDA product code for COAG-A-MATE X2 is GKP.

Other records listing General Diagnostics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 39 devices →

Related Devices (Code: GKP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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