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FDA 510(k)

COAG-A-MATE MTX

K-Number: K962857 · 1997-01-22

Decision Date1997-01-22
Product CodeGKP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAG-A-MATE MTX is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1997-01-22 under 510(k) number K962857. 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 MTX?

COAG-A-MATE MTX is a medical device that received FDA 510(k) clearance on 1997-01-22. The listed applicant is Organon Teknika Corp.. The 510(k) number is K962857.

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

COAG-A-MATE MTX received FDA 510(k) clearance on 1997-01-22, under 510(k) number K962857.

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

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

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

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

Other records listing Organon Teknika Corp. 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 130 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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